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Domvanalimab

Phase 3

Advanced Upper Gastrointestinal Tract Adenocarcinoma | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: Jun 2, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,040
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05568095A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the BodyPHASE3 ACTIVE NOT_RECRUITING 1,040 — — Nov 21, 2022Jun 1, 2026Jun 2, 2026168 United States, Argentina +27
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Study Endpoints
Primary Endpoints
Overall survival
From date of randomization until date of death from any cause (Approximately 15 months)]
Secondary Endpoints
Progression-free survival (PFS)
From date of randomization to date of the first documentation of disease progression or date of death from any cause, whichever comes first (Approximately 15 months)
Objective response rate (ORR)
Proportion of randomized participants who achieved a confirmed best overall response of complete response (CR) or partial response (PR) (Approximately 15 months)
Duration of response (DOR)
From the date of first confirmed response (CR or PR), until the date of first documented disease progression or date of death from any cause, whichever comes first (Approximately 15 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)EXPERIMENTALParticipants in this arm will receive Domvanalimab and zimberelimab doses once every 4 weeks (Q4W) in addition to chemotherapy with FOLFOX (oxaliplatin, leucovorin, fluorouracil) once every 2 weeks (Q2W) or Domvanalimab and zimberelimab once every 3 weeks (Q3W) in addition to chemotherapy with CAPOX (capecitabine and oxaliplatin) Q3W.
Nivolumab + FOLFOX/CAPOX (PI Choice)ACTIVE_COMPARATORParticipants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W.
Interventions
NameTypeDescription
DomvanalimabDRUGIntravenous (IV) Aqueous Solution
ZimberelimabDRUGIV Aqueous Solution
CapecitabineDRUGOral Tablets
FluorouracilDRUGIV Aqueous Solution
LeucovorinDRUGIV Aqueous Solution
OxaliplatinDRUGIV Aqueous Solution
NivolumabDRUGIV Aqueous Solution
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites168

Key Inclusion Criteria: * Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol. * Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophagea...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileChinaFranceGeorgiaGuatemalaHong KongHungaryIsraelItalyJapanLithuaniaMalaysiaMexicoPeruPhilippinesPolandPortugalRomaniaSerbiaSouth KoreaSpainThailandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT05568095lastUpdatePostDate: changed
LOWJun 2, 2026NCT05568095lastUpdatePostDate: changed
LOWJun 2, 2026NCT05568095lastUpdatePostDate: changed
LOWMay 26, 2026NCT05568095primaryCompletionDate: changed
LOWMay 24, 2026NCT05568095studyFirstPostDate: changed