Gilead Sciences Clinical Trials: 728 Led Studies

Archive historyOct 2022 to Jun 2026

124 recorded changes across Gilead Sciences trials

Every status move, completion date shift and enrollment change ComplyRx has recorded across 37 of these trials. One is shown below.

Status changeStatus moved to recruiting from not yet recruitingNCT07546812 · recorded 1 Jun 2026

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+120 more recorded changes · Track a drug to see every change the night it lands

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Most active programmes

The drugs appearing most often across Gilead Sciences's recently active trials. Comparator arms are excluded.

Fludarabine14 trials
Cyclophosphamide14 trials
Lenacapavir Tablet9 trials
Sacituzumab govitecan9 trials
Zimberelimab9 trials
Lenacapavir Injection7 trials

Upcoming readouts

Next primary completion dates among Gilead Sciences's active phase 2 and phase 3 trials. Dates are registry estimates and move often, which is exactly what the tracker watches.

Jan 2027PALEKONA: Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative C…Phase 2
Mar 2027Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adoles…Phase 2
Jun 2027Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in …Phase 3
Aug 2027A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed P…Phase 2
Dec 2028Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With A…Phase 2
Oct 2029EVOKE-SCLC-04: Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated E…Phase 3

Top therapeutic areas

Conditions studied most often across Gilead Sciences's recently active trials.

HIV-1-infection14 trials
HIV Infections4 trials
Pre-Exposure Prophylaxis of HIV Infection4 trials
Primary Biliary Cholangitis3 trials
Solid Tumor3 trials
Triple Negative Breast Cancer3 trials

Gilead Sciences trials

The 50 most significant of Gilead Sciences's recently active trials, soonest estimated readout first.
Select any row for the full record; the change timeline unlocks with tracking.

Trial	Phase	Stability	Status	Enrollment	Est. readout
VELOCITY-HNSCCStudy of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01NCT06727565Domvanalimab	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	100 est.	Aug 2026
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus InfectionNCT02932150TAF	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	150 est.	Sept 2026
EVOKE-02Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)NCT05186974Sacituzumab Govitecan-hziy (SG)	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	193 est.	Sept 2026
Study of Sacituzumab Govitecan in Patients With Solid TumorNCT05119907Sacituzumab Govitecan-hziy	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	53 est.	Oct 2026
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)NCT06562907GS-4571	Phase 1	Locked · track to reveal	OngoingRecruiting	134 est.	Nov 2026
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver ImpairmentNCT04617522Sacituzumab Govitecan-hziy	Phase 1	Locked · track to reveal	OngoingRecruiting	30 est.	Dec 2026
Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)NCT04639986Sacituzumab Govitecan-hziy	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	331 est.	Dec 2026
iMMagine-1Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)NCT05396885anitocabtagene-autoleucel	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	136 est.	Dec 2026
Study of GS-9911 With or Without Antibody Treatment for Adults With Solid TumorsNCT06082960GS-9911	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	45 est.	Dec 2026
PALEKONAStudy of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative ColitisNCT06029972Tilpisertib Fosmecarbil	Phase 2	Locked · track to reveal	OngoingRecruiting	176 est.	Jan 2027
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and ChildrenNCT06749054Oral Lenacapavir	Phase 2	Locked · track to reveal	OngoingRecruiting	12 est.	Mar 2027
Study of GS-0151 in Participants With Rheumatoid ArthritisNCT06902519GS-0151	Phase 1	Locked · track to reveal	OngoingRecruiting	75 est.	Mar 2027
ASCENT-J02Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid TumorsNCT05101096Sacituzumab Govitecan-hziy	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	135 est.	May 2027
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)NCT05633654Sacituzumab govitecan-hziy (SG)	Phase 3	Locked · track to reveal	OngoingRecruiting	1,514 est.	Jun 2027
JKART-1Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaNCT06253663KTE-X19	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	25 est.	Jul 2027
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1NCT07645287GS-3242 Tablet	Phase 2	Not yet scored	OngoingRecruiting	175 est.	Aug 2027
EDGE-LungStudy With Various Immunotherapy Treatments in Participants With Lung CancerNCT05676931Domvanalimab	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	400 est.	Dec 2027
WONDERS1Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically SuppressedNCT06544733Lepetegravir	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	675 est.	Jan 2028
PURPOSE 4Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)NCT06101342Lenacapavir Injection	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	181 est.	Jan 2028
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIVNCT07055451B/F/TAF	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	16 est.	Mar 2028
PROPELImplementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV PreventionNCT07473778Lenacapavir Injection	—	Not yet scored	OngoingRecruiting	3,000 est.	Apr 2028
Study of GS-5319 in Adults With Solid TumorsNCT07128303GS-5319	Phase 1	Locked · track to reveal	OngoingRecruiting	178 est.	May 2028
Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid TumorsNCT06532565GS-2121	Phase 1	Locked · track to reveal	OngoingRecruiting	154 est.	Jun 2028
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast CancerNCT06926920Sacituzumab Govitecan-hziy (SG)	Phase 1	Locked · track to reveal	OngoingRecruiting	100 est.	Jun 2028
STAR-121Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung CancerNCT05502237Zimberelimab	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	1,021 est.	Jun 2028
iMMagine-3A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple MyelomaNCT06413498Anitocabtagene Autoleucel	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	452 est.	Jul 2028
ASCENT-03Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast CancerNCT05382299Sacituzumab Govitecan-hziy	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	623 est.	Jul 2028
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid TumorsNCT06167317GS-0201	Phase 1	Locked · track to reveal	OngoingRecruiting	278 est.	Sept 2028
PURPOSE 365Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)NCT07047716Lenacapavir Injection	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	339 est.	Sept 2028
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)NCT03301506Seladelpar 5 mg Capsule	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	340 est.	Nov 2028
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal CancerNCT07527858Denikitug	Phase 2	Locked · track to reveal	OngoingRecruiting	170 est.	Dec 2028
Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid TumorsNCT05007782Denikitug	Phase 1	Locked · track to reveal	OngoingRecruiting	416 est.	Dec 2028
Study of GS-2426 in Participants With Advanced Solid TumorsNCT07601243GS-2426	Phase 1	Locked · track to reveal	OngoingRecruiting	174 est.	Jan 2029
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral TherapyNCT07682961Lenacapavir	Phase 3	Not yet scored	OngoingNot yet recruiting	590 est.	Mar 2029
Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment RegimensNCT07683000Lenacapavir	Phase 3	Not yet scored	OngoingNot yet recruiting	590 est.	Mar 2029
A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic DiseasesNCT07304154KITE-363	Phase 1	Locked · track to reveal	OngoingRecruiting	52 est.	Jun 2029
ASCENT-GYN-01Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)NCT06486441Sacituzumab govitecan-hziy	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	640 est.	Jun 2029
A Study of KITE-363 in Participants With Refractory Autoimmune DiseasesNCT07038447KITE-363	Phase 1	Locked · track to reveal	OngoingEnrolling by invitation	52 est.	Jul 2029
VELOCITY-LungStudy of Novel Treatment Combinations in Patients With Lung CancerNCT05633667Zimberelimab (ZIM)	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	192 est.	Sept 2029
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid TumorsNCT07703878GS-1206	Phase 1	Not yet scored	OngoingNot yet recruiting	302 est.	Sept 2029
EVOKE-SCLC-04Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung CancerNCT06801834Sacituzumab Govitecan (SG)	Phase 3	Locked · track to reveal	OngoingRecruiting	695 est.	Oct 2029
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal AdenocarcinomasNCT07546812Denikitug	Phase 2	Locked · track to reveal	OngoingRecruiting	120 est.	Jan 2030
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta VirusNCT07096193GS-4321	Phase 1	Locked · track to reveal	OngoingRecruiting	200 est.	Jan 2030
PALISADES-1Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell LymphomaNCT04989803Cyclophosphamide	Phase 1	Locked · track to reveal	OngoingRecruiting	247 est.	Feb 2030
TROPHY U-01Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has SpreadNCT03547973Sacituzumab Govitecan-hziy	Phase 2	Locked · track to reveal	OngoingRecruiting	827 est.	Apr 2030
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1NCT06532656Lenacapavir	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	75 est.	Jul 2030
AFFIRMSeladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated CirrhosisNCT06051617Seladelpar	Phase 3	Locked · track to reveal	OngoingRecruiting	318 est.	Aug 2030
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 TreatmentNCT07708727GS-3242 Tablet	Phase 2	Not yet scored	OngoingNot yet recruiting	700 est.	Oct 2030
ZUMA-23Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell LymphomaNCT05605899Axicabtagene Ciloleucel	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	300 est.	Mar 2031
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line TherapyNCT07479797KITE-753	Phase 3	Locked · track to reveal	OngoingRecruiting	550 est.	May 2031

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VELOCITY-HNSCC: Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01

Phase 2Active, not recruitingNCT06727565 ↗

Primary completion: Aug 2026; estimated
Enrollment: 100; estimated
Start: Feb 2025; Gilead Sciences

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Domvanalimab
Zimberelimab
Paclitaxel
Carboplatin

Brief summary

Master protocol: The main goal of this master clinical study is to evaluate the efficacy and safety of multiple novel combination therapies in participants with head and neck squamous cell carcinoma (HNSCC) in various substudies. Substudy-01 will evaluate the efficacy and safety of novel combination of treatment…

Full record on ClinicalTrials.gov ↗

Change timeline

2 recorded · latest 1 Apr 2026

Status change · 2

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EVOKE-02: Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

Phase 2Active, not recruitingNCT05186974 ↗

Primary completion: Sept 2026; estimated
Enrollment: 193; estimated
Start: May 2022; Gilead Sciences

Conditions

Non-small Cell Lung Cancer

Interventions

Sacituzumab Govitecan-hziy (SG)
Pembrolizumab
Carboplatin
Cisplatin

Brief summary

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer…

Full record on ClinicalTrials.gov ↗

Change timeline

6 recorded · latest 1 Mar 2026

Completion date move · 3

Enrollment change · 2

Status change · 1

Track Gilead Sciences drugs to see every change the night it lands.

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Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)

Phase 3Active, not recruitingNCT04639986 ↗

Primary completion: Dec 2026; estimated
Enrollment: 331; estimated
Start: Nov 2020; Gilead Sciences

Conditions

Metastatic Breast Cancer

Interventions

Sacituzumab Govitecan-hziy
Eribulin Mesylate Injection
Capecitabine Oral Product
Gemcitabine Injection
Vinorelbine injection

Brief summary

The goal of this study is to compare the study drug, sacituzumab govitecan-hziy, versus doctors' treatment of choice in participants with HR+/HER2- metastatic breast cancer (MBC) who have failed at least 2 prior chemotherapy regimens.

Full record on ClinicalTrials.gov ↗

Change timeline

7 recorded · latest 1 Mar 2026

Completion date move · 5

Status change · 1

Enrollment change · 1

Track Gilead Sciences drugs to see every change the night it lands.

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Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

Phase 1Active, not recruitingNCT06082960 ↗

Primary completion: Dec 2026; estimated
Enrollment: 45; estimated
Start: Oct 2023; Gilead Sciences

Conditions

Solid Tumors

Interventions

GS-9911
Zimberelimab

Brief summary

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. The primary objectives of this study are to: * Assess the safety…

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 May 2026

Completion date move · 1

Enrollment change · 1

Status change · 1

Track Gilead Sciences drugs to see every change the night it lands.

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PALEKONA: Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2RecruitingNCT06029972 ↗

Primary completion: Jan 2027; estimated
Enrollment: 176; estimated
Start: Dec 2023; Gilead Sciences

Conditions

Ulcerative Colitis

Interventions

Tilpisertib Fosmecarbil
Placebo

Brief summary

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with…

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Mar 2026

Completion date move · 2

Status change · 1

Track Gilead Sciences drugs to see every change the night it lands.

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Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

Phase 2RecruitingNCT06749054 ↗

Primary completion: Mar 2027; estimated
Enrollment: 12; estimated
Start: Mar 2025; Gilead Sciences

Conditions

HIV-1-infection

Interventions

Oral Lenacapavir
Subcutaneous Lenacapavir
Optimized Background Regimen (OBR)

Brief summary

The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 May 2026

Completion date move · 3

Status change · 1

Track Gilead Sciences drugs to see every change the night it lands.

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ASCENT-J02: Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors

Phase 1Active, not recruitingNCT05101096 ↗

Primary completion: May 2027; estimated
Enrollment: 135; estimated
Start: Oct 2021; Gilead Sciences

Conditions

Advanced Solid Tumor
Metastatic Triple-Negative Breast Cancer
HR+/HER2- Metastatic Breast Cancer
Metastatic Urothelial Cancer

Interventions

Sacituzumab Govitecan-hziy

Brief summary

The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose (RP2D) of SG in Japanese participants with advance solid tumors. Phase 2: Evaluate the…

Full record on ClinicalTrials.gov ↗

Change timeline

8 recorded · latest 1 Oct 2024

Status change · 3

Enrollment change · 3

Completion date move · 2

Track Gilead Sciences drugs to see every change the night it lands.

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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

Phase 3RecruitingNCT05633654 ↗

Primary completion: Jun 2027; estimated
Enrollment: 1,514; estimated
Start: Dec 2022; Gilead Sciences

Conditions

Triple Negative Breast Cancer

Interventions

Sacituzumab govitecan-hziy (SG)
Pembrolizumab
Capecitabine

Brief summary

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants…

Full record on ClinicalTrials.gov ↗

Change timeline

1 recorded · latest 1 Oct 2023

Completion date move · 1

Track Gilead Sciences drugs to see every change the night it lands.

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JKART-1: Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Phase 2Active, not recruitingNCT06253663 ↗

Primary completion: Jul 2027; estimated
Enrollment: 25; estimated
Start: Mar 2024; Kite, A Gilead Company

Conditions

Relapsed/Refractory Mantle Cell Lymphoma
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Interventions

KTE-X19
Cyclophosphamide
Fludarabine

Brief summary

The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic Leukemia (B-ALL). The primary objectives of this study are to evaluate the efficacy of…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Jan 2026

Completion date move · 2

Enrollment change · 1

Status change · 1

Track Gilead Sciences drugs to see every change the night it lands.

Track sacituzumab govitecan

EDGE-Lung: Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Phase 2Active, not recruitingNCT05676931 ↗

Primary completion: Dec 2027; estimated
Enrollment: 400; estimated
Start: Feb 2023; Gilead Sciences

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

Domvanalimab
Quemliclustat
Zimberelimab
Docetaxel
Platinum-Based Doublet

Brief summary

The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Nov 2025

Status change · 1

Enrollment change · 1

Completion date move · 1

Track Gilead Sciences drugs to see every change the night it lands.

Track sacituzumab govitecan

WONDERS1: Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

Phase 2Active, not recruitingNCT06544733 ↗

Primary completion: Jan 2028; estimated
Enrollment: 675; estimated
Start: Aug 2024; Gilead Sciences

Conditions

HIV-1-Infection

Interventions

Lepetegravir
Lenacapavir pacfosacil
Placebo to Match BVY
Bictegravir/emtricitabine/tenofovir alafenamide
Lepetegravir/Lenacapavir pacfosacil FDC
Placebo to Match GS1720/GS-4182 FDC

Brief summary

The goal of this clinical study is to learn more about the experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the…

Full record on ClinicalTrials.gov ↗

Change timeline

1 recorded · latest 1 Apr 2025

Status change · 1

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PURPOSE 4: Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

Phase 2Active, not recruitingNCT06101342 ↗

Primary completion: Jan 2028; estimated
Enrollment: 181; estimated
Start: Dec 2023; Gilead Sciences

Conditions

Pre-Exposure Prophylaxis of HIV Infection

Interventions

Lenacapavir Injection
Lenacapavir Tablet
Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Brief summary

The goals of this clinical study are to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US). The primary objectives of this study…

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Apr 2026

Completion date move · 2

Enrollment change · 2

Status change · 1

Track Gilead Sciences drugs to see every change the night it lands.

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PROPEL: Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

–RecruitingNCT07473778 ↗

Primary completion: Apr 2028; estimated
Enrollment: 3,000; estimated
Start: Mar 2026; Gilead Sciences

Conditions

HIV Infections

Interventions

Lenacapavir Injection
Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
Emtricitabine/tenofovir alafenamide (F/TAF)
Cabotegravir (CAB)
Lenacapavir Tablet

Brief summary

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Phase 3Active, not recruitingNCT05502237 ↗

Primary completion: Jun 2028; estimated
Enrollment: 1,021; estimated
Start: Oct 2022; Gilead Sciences

Conditions

Non-small Cell Lung Cancer

Interventions

Zimberelimab
Domvanalimab
Pembrolizumab
Carboplatin
Cisplatin
Paclitaxel
Nab-paclitaxel
Pemetrexed

Brief summary

The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable…

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9 recorded · latest 1 Feb 2026

Status change · 4

Enrollment change · 3

Completion date move · 2

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iMMagine-3: A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

Phase 3Active, not recruitingNCT06413498 ↗

Primary completion: Jul 2028; estimated
Enrollment: 452; estimated
Start: Aug 2024; Kite, A Gilead Company

Conditions

Multiple Myeloma

Interventions

Anitocabtagene Autoleucel
Cyclophosphamide
Fludarabine
Pomalidomide
Bortezomib
Dexamethasone
Daratumumab
Carfilzomib

Brief summary

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary…

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1 recorded · latest 1 Oct 2024

Status change · 1

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ASCENT-03: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Phase 3Active, not recruitingNCT05382299 ↗

Primary completion: Jul 2028; estimated
Enrollment: 623; estimated
Start: Jul 2022; Gilead Sciences

Conditions

Triple Negative Breast Cancer
PD-L1 Negative

Interventions

Sacituzumab Govitecan-hziy
Paclitaxel
nab-Paclitaxel
Gemcitabine
Carboplatin

Brief summary

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express…

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3 recorded · latest 1 Oct 2025

Status change · 1

Enrollment change · 1

Completion date move · 1

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PURPOSE 365: Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)

Phase 3Active, not recruitingNCT07047716 ↗

Primary completion: Sept 2028; estimated
Enrollment: 339; estimated
Start: Jul 2025; Gilead Sciences

Conditions

HIV Pre-exposure Prophylaxis

Interventions

Lenacapavir Injection
Lenacapavir Tablet

Brief summary

The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an…

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2 recorded · latest 1 Apr 2026

Enrollment change · 1

Status change · 1

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Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer

Phase 2RecruitingNCT07527858 ↗

Primary completion: Dec 2028; estimated
Enrollment: 170; estimated
Start: May 2026; Gilead Sciences

Conditions

Advanced Microsatellite Stable Colorectal Cancer

Interventions

Denikitug
Nivolumab
Bevacizumab
Trifluridine-Tipiracil

Brief summary

The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based Combinations in participants with advanced microsatellite stable (MSS) colorectal cancer (CRC). The primary objective of this study is to…

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No changes recorded on this trial in the observed window.

Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors

Phase 1RecruitingNCT05007782 ↗

Primary completion: Dec 2028; estimated
Enrollment: 416; estimated
Start: Aug 2021; Gilead Sciences

Conditions

Advanced Solid Tumor

Interventions

Denikitug
Zimberelimab

Brief summary

This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors. This study will…

Full record on ClinicalTrials.gov ↗

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6 recorded · latest 1 Aug 2025

Completion date move · 3

Enrollment change · 3

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Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

Phase 3Not yet recruitingNCT07682961 ↗

Primary completion: Mar 2029; estimated
Enrollment: 590; estimated
Start: Jul 2026; Gilead Sciences

Conditions

HIV Infections

Interventions

Lenacapavir
Lenacapavir Tablet
Teropavimab
Zinlirvimab
Cabotegravir
Rilpivirine

Brief summary

The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52…

Full record on ClinicalTrials.gov ↗

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No changes recorded on this trial in the observed window.

A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases

Phase 1RecruitingNCT07304154 ↗

Primary completion: Jun 2029; estimated
Enrollment: 52; estimated
Start: Apr 2026; Kite, A Gilead Company

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy
Myasthenia Gravis
Multiple Sclerosis

Interventions

KITE-363
Fludarabine
Cyclophosphamide

Brief summary

This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed/refractory autoimmune neurologic diseases. The primary objectives of this study are: * To…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 May 2026

Status change · 1

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ASCENT-GYN-01: Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)

Phase 3Active, not recruitingNCT06486441 ↗

Primary completion: Jun 2029; estimated
Enrollment: 640; estimated
Start: Aug 2024; Gilead Sciences

Conditions

Endometrial Cancer

Interventions

Sacituzumab govitecan-hziy
Doxorubicin
Paclitaxel

Brief summary

The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC). The primary objectives of this study are…

Full record on ClinicalTrials.gov ↗

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2 recorded · latest 1 Feb 2026

Status change · 1

Enrollment change · 1

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A Study of KITE-363 in Participants With Refractory Autoimmune Diseases

Phase 1Enrolling by invitationNCT07038447 ↗

Primary completion: Jul 2029; estimated
Enrollment: 52; estimated
Start: Jul 2025; Kite, A Gilead Company

Conditions

Systemic Lupus Erythematosus
Lupus Nephritis
Systemic Sclerosis
Idiopathic Inflammatory Myopathy

Interventions

KITE-363
Fludarabine
Cyclophosphamide

Brief summary

This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in participants with refractory autoimmune diseases. The primary objectives of this study are: Phase…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Aug 2025

Status change · 1

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VELOCITY-Lung: Study of Novel Treatment Combinations in Patients With Lung Cancer

Phase 2Active, not recruitingNCT05633667 ↗

Primary completion: Sept 2029; estimated
Enrollment: 192; estimated
Start: Mar 2023; Gilead Sciences

Conditions

Lung Cancer
Advanced or Metastatic Non-Small-Cell Lung Cancer
Resectable Non-Small-Cell Lung Cancer

Interventions

Zimberelimab (ZIM)
Domvanalimab (DOM)
Sacituzumab govitecan-hziy (SG)
Etrumadenant (ETRUMA)
Carboplatin
Cisplatin
Pemetrexed
Paclitaxel

Brief summary

The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not…

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5 recorded · latest 1 Apr 2026

Enrollment change · 3

Completion date move · 1

Status change · 1

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EVOKE-SCLC-04: Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Phase 3RecruitingNCT06801834 ↗

Primary completion: Oct 2029; estimated
Enrollment: 695; estimated
Start: Apr 2025; Gilead Sciences

Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Interventions

Sacituzumab Govitecan (SG)
Topotecan
Amrubicin (Japan only)
Lurbinectedin (regions/countries where approved and available)

Brief summary

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas

Phase 2RecruitingNCT07546812 ↗

Primary completion: Jan 2030; estimated
Enrollment: 120; estimated
Start: Jul 2026; Gilead Sciences

Conditions

HER2-negative
Gastroesophageal Junction
Esophageal Adenocarcinoma
Gastric Adenocarcinoma

Interventions

Denikitug
Nivolumab
Ramucirumab
Paclitaxel

Brief summary

The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and/or metastatic,…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Jun 2026

Status change · 1

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Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus

Phase 1RecruitingNCT07096193 ↗

Primary completion: Jan 2030; estimated
Enrollment: 200; estimated
Start: Jul 2025; Gilead Sciences

Conditions

Chronic Hepatitis Delta

Interventions

GS-4321
GS-4321 Placebo
GS-4321

Brief summary

The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD). The primary objective of Phase 1 of this study is to evaluate…

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3 recorded · latest 1 Nov 2025

Completion date move · 1

Enrollment change · 1

Status change · 1

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TROPHY U-01: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

Phase 2RecruitingNCT03547973 ↗

Primary completion: Apr 2030; estimated
Enrollment: 827; estimated
Start: Aug 2018; Gilead Sciences

Conditions

Metastatic Urothelial Cancer

Interventions

Sacituzumab Govitecan-hziy
Pembrolizumab
Cisplatin
Avelumab
Zimberelimab
Carboplatin
Gemcitabine
Domvanalimab

Brief summary

The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).

Full record on ClinicalTrials.gov ↗

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4 recorded · latest 1 Apr 2026

Completion date move · 2

Enrollment change · 2

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ZUMA-23: Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

Phase 3Active, not recruitingNCT05605899 ↗

Primary completion: Mar 2031; estimated
Enrollment: 300; estimated
Start: Feb 2023; Kite, A Gilead Company

Conditions

High-risk Large B-cell Lymphoma (LBCL)

Interventions

Axicabtagene Ciloleucel
Cyclophosphamide
Fludarabine
Etoposide
Rituximab
Doxorubicin
Vincristine
Prednisone

Brief summary

The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.

Full record on ClinicalTrials.gov ↗

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2 recorded · latest 1 May 2026

Status change · 2

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Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

Phase 3RecruitingNCT07479797 ↗

Primary completion: May 2031; estimated
Enrollment: 550; estimated
Start: May 2026; Kite, A Gilead Company

Conditions

Relapsed or Refractory Large B-cell Lymphoma

Interventions

KITE-753
Axicabtagene Ciloleucel
Fludarabine
Cyclophosphamide

Brief summary

The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy. The primary objective of this study is to evaluate the efficacy of KITE-753 versus…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Jun 2026

Status change · 1

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