OncoMatch/Clinical Trials/NCT07432295
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
Is NCT07432295 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for solid tumor.
Treatment: Givastomig · Nivolumab · 5Fluorouracil · Leucovorin · Oxaliplatin · Capecitabine — The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are: * Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer? * What toxicities do participants experience when taking givastomig? Participants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part. Up to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks. Participants will: * Visit the study treatment center for infusions and/or check-ups and tests every 1-3 weeks * Report any changes in their symptoms to their study doctors * Have scans to check for any changes in their cancer every 8-12 weeks
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: CLDN18 positive (membrane intensity score ≥1+ on ≥1% of tumor cells) (membrane intensity score ≥1+ on ≥1% of tumor cells)
CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells)
Required: PD-L1 (CD274) positive (CPS ≥1) (CPS ≥1)
PD-L1 positive (CPS ≥1)
Required: HER2 (ERBB2) wild-type
HER2-positive tumors [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
wbc ≥2,000/μl; anc ≥1,500/μl; platelets ≥100,000/μl; hemoglobin ≥9 g/dl
Kidney function
creatinine ≤1.5×uln or egfr ≥50 ml/min/1.73 m²
Liver function
ast/alt ≤3×uln (≤5×uln if liver metastases); bilirubin ≤1.5×uln (≤3×uln if gilbert's)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- I-Mab Site 1016 · Goodyear, Arizona
- I-MAB Site 1005 · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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