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Givastomig

Phase 2

Solid Tumor | Small molecule | Oncology |I-Mab Sponsored ADR|Last Updated: May 14, 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 Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07432295Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)PHASE2 RECRUITING 180 — — Feb 11, 2026Aug 1, 2030May 14, 20266 United States, China +1
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Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS), BICR-assessed
Up to 5 years

Compare PFS between participants receiving givastomig plus nivolumab and chemotherapy versus control (nivolumab plus chemotherapy)

Safety and Tolerability
Throughout treatment and up to 30 days after last dose

Incidence, severity, and type of adverse events, including treatment-emergent and immune-related adverse events, graded by NCI CTCAE v5.0

Secondary Endpoints
Objective Response Rate (ORR), BICR-assessed
Up to 108 weeks
Duration of Response (DOR), BICR-assessed
Up to 108 weeks
Best Overall Response (BOR), BICR-assessed
Up to 108 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental: Givastomig Arm 1 CombinationEXPERIMENTALGivastomig (IV) 8 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 12 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX
Experimental: Givastomig Arm 2 CombinationEXPERIMENTALGivastomig (IV) 12 mg/kg every 2 weeks (Q2W) in combination with nivolumab and modified FOLFOX (mFOLFOX) or Givastomig 18 mg/kg every 3 weeks (Q3W) in combination with nivolumab and CAPOX
Control: Nivolumab Plus ChemotherapyACTIVE_COMPARATORNivolumab in combination with modified FOLFOX (mFOLFOX) or CAPOX
Interventions
NameTypeDescription
GivastomigDRUGGivastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV
NivolumabDRUGQ2 or Q3W IV
5FluorouracilDRUGQ2W IV
LeucovorinDRUGQ2W IV
OxaliplatinDRUGQ2W or Q3W IV
CapecitabineDRUGTwice daily x 14 days every 3 weeks PO
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC). * Treatment-naïve for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy allowed if ≥6 months since last dose). * C...

Countries:United StatesChinaJapan
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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, 2026NCT07432295primaryCompletionDate: changed
LOWMay 24, 2026NCT07432295studyFirstPostDate: changed