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GS-4528

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Last Updated: Jul 27, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment182

FDA Designations

No designations recorded

Clinical trial landscape

GS-4528 · 1 trial · 1 indication

Phase 1 1
NCT05840224Study of GS-4528 in Adults With Solid TumorsSolid Tumor
ACTIVE NOT_RECRUITING182 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of GS-4528 in Adults With Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
First dose date up to 90 days post last dose (Up to 24 months)
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Day 1 up to 4 weeks
Maximum Tolerable Dose (MTD) of GS-4528
Day 1 up to 4 weeks

Secondary Endpoints

Pharmacokinetic (PK) parameter: Cmax of GS-4528 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody
Predose on Day 1 and post dose up to end of treatment (EOT, Up to 24 months)
PK parameter: Cmin of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Predose on Day 1 and post dose up to EOT (Up to 24 months)
PK parameter: AUC of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Predose on Day 1 and post dose up to EOT (Up to 24 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a: GS-4528 Monotherapy Dose EscalationEXPERIMENTALParticipants will receive escalating doses of GS-4528 monotherapy to determine the maximum tolerated dose.
Phase 1a: GS-4528 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive GS-4528 monotherapy at the dose determined in the escalation phase.
Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)EXPERIMENTALParticipants will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody (zimberelimab) to determine the maximum tolerated dose of GS-4528 as a combination therapy.

Interventions

NameTypeDescription
GS-4528BIOLOGICALAdministered intravenously
ZimberelimabDRUGAdministered intravenously.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Key Inclusion Criteria: * Documented disease: * Phase 1a dose escalation and backfill cohorts; Phase 1b dose escalation: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer cl...

Countries:United StatesCanadaSouth KoreaSpainTaiwanUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Recent Changes (Last 90 Days)

MEDIUMJul 27, 2026NCT05840224primaryCompletionDate: changed
MEDIUMJul 27, 2026NCT05840224primaryCompletionDate: changed
MEDIUMJul 27, 2026NCT05840224primaryCompletionDate: changed

Frequently asked questions about GS-4528

What is GS-4528 used for?

GS-4528 is an investigational monoclonal antibody being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in adults with solid tumors to evaluate its safety and potential efficacy.

What does GS-4528 target?

GS-4528 is a monoclonal antibody, but its specific molecular target has not been disclosed. As an antibody-based therapy, it is designed to bind to a particular antigen involved in tumor growth, though the exact target is not publicly available at this time.

Who makes GS-4528?

GS-4528 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting clinical research on this drug for the treatment of solid tumors.

What phase is GS-4528 in?

GS-4528 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary activity of the drug in patients with solid tumors.

What clinical trials is GS-4528 in?

GS-4528 is being studied in a Phase 1 clinical trial identified as NCT05840224, titled 'Study of GS-4528 in Adults With Solid Tumors.' The trial is active but not recruiting, with an enrollment of 182 participants across the United States, Canada, South Korea, Spain, Taiwan, and the United Kingdom.