NCT07432295
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
Recruiting
PHASE2Ages 18+InterventionalTreatmentI-Mab Biopharma US Limited
~180 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:GivastomigNivolumab5FluorouracilLeucovorinOxaliplatinCapecitabine
At a glance
Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS), BICR-assessed
Measured over Up to 5 years
+1 more outcome measured
Conditions
Where it's being run
6 sites across 5 statesJapan2
Arizona1
California1
Massachusetts1
China1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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).
CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).
PD-L1 positive (CPS ≥1).
At least 1 measurable lesion per RECIST v1.1.
ECOG performance status 0 or 1.
Adequate organ function, including:
Hematologic: WBC ≥2,000/μL; ANC ≥1,500/μL; platelets ≥100,000/μL; hemoglobin ≥9 g/dL
Hepatic: AST/ALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)
Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL/min/1.73 m²
Life expectancy ≥90 days.
Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment.
Willing and able to provide informed consent and comply with study procedures
Exclusion
HER2-positive tumors.
Second malignancy within 3 years, except certain skin or cervical cancers.
Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.
Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.
Active pneumonitis or history requiring steroids/immunosuppressive therapy within 3 years.
Participation in another therapeutic clinical trial.
Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months.
Radiotherapy within protocol-specified timeframes without adequate recovery.
Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable).
Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA/stroke, or major cardiac procedures within 6 months).
Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).
Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose.
Active infection requiring parenteral therapy.
Known hypersensitivity to study drug components (e.g., DPD deficiency).
Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.
What this trial measures
- Progression-Free Survival (PFS), BICR-assessedUp to 5 years
Compare PFS between participants receiving givastomig plus nivolumab and chemotherapy versus control (nivolumab plus chemotherapy)
- Safety and TolerabilityThroughout 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