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Single agent zimberelimab

Phase 2

Locally Advanced Gastric Adenocarcinoma | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 21, 2025

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06250036Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric CancerPHASE2 RECRUITING 50 — — Feb 20, 2025Sep 1, 2031Aug 21, 20259 United Kingdom
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Study Endpoints
Primary Endpoints
Efficacy of zimberelimab +/- domvanalimab in patients with resectable MMRd/MSI-H gastric/GOJ adenocarcinoma who proceed to surgery
5 years

Complete pathological response (pCR) rate, to be assessed following surgery by pathological review pCR defined as complete disappearance of tumour cells in the primary tumour surgical specimen and lymph nodes, pCR graded using Mandard TRG grading system

Secondary Endpoints
Efficacy of zimberelimab +/- domvanalimab in patients with resectable MMRd/MSI-H gastric/GOJ adenocarcinoma (all patients treated with study drug(s))
5 years
Assess the safety of zimberelimab+/- domvanalimab with the incidence of TEAEs, SAEs, AEs leading to discontinuation or delays, irAEs, deaths and laboratory abnormalities per CTCAEv5 grade
5 years
Further assess the anti-tumour effect of zimberelimab +/- domvanalimab and any additional benefit of domvanalimab with radiological response, R0 resection rate, and major surgical complications and survival
5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single agent zimberelimabEXPERIMENTALSingle agent zimberelimab (PD-1 inhibitor) Q3W
Combination zimberelimab + domvanalimabEXPERIMENTALCombination zimberelimab + domvanalimab (anti-TIGIT) Q3W
Interventions
NameTypeDescription
Single agent zimberelimabDRUGSingle agent zimberelimab (PD-1 inhibitor) Q3W
Combination zimberelimab + domvanalimabDRUGCombination zimberelimab + domvanalimab (TIGIT inhibitor) Q3W
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria * Age: ≥18 years * Histologically confirmed gastric or gastro-oesophageal junctional (GOJ) adenocarcinoma (inclusive of Siewert-stein classification type I-III (62)) * MMRd/MSI-H. There are three different methods validated for detection (63) : * Immunohistochemistry (IHC) sta...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06250036studyFirstPostDate: changed