OncoMatch/Clinical Trials/NCT07431281
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
Is NCT07431281 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for gastric cancer.
Treatment: Sonesitatug vedotin · Rilvegostomig · Nivolumab · Capecitabine · 5-Fluorouracil · Oxaliplatin · Zolbetuximab · Leucovorin — The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: CLDN18 positive expression
Positive CLDN18.2 expression, as determined prospectively by central IHC testing
Required: PD-L1 (CD274) positive expression (Cohort 1: PD-L1 positive as determined by central IHC testing)
Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.
Required: PD-L1 (CD274) negative expression (Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible)
Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible
Excluded: HER2 (ERBB2) positive
Known HER2-positive status
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Adequate organ and bone marrow function as specified in the protocol
Kidney function
Adequate organ and bone marrow function as specified in the protocol
Liver function
Adequate organ and bone marrow function as specified in the protocol
Cardiac function
Cardiac abnormalities as outlined in the protocol [excluded]
Adequate organ and bone marrow function as specified in the protocol; Cardiac abnormalities as outlined in the protocol [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Phoenix, Arizona
- Research Site · Duarte, California
- Research Site · La Jolla, California
- Research Site · Orange, California
- Research Site · Walnut Creek, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07431281 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CLDN18?
Yes, CLDN18 positive expression is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 positive expression is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 negative expression is a required biomarker for enrollment.
Are patients with ERBB2 alterations eligible?
No. ERBB2 positive is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify