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GS-4528

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Last Updated: Jan 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment182
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05840224Study of GS-4528 in Adults With Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 182 — — May 11, 2023Jul 1, 2026Jan 28, 202616 United States, Canada +4
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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 — 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
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05840224primaryCompletionDate: changed
LOWMay 24, 2026NCT05840224studyFirstPostDate: changed