Givastomig with nivolumab and chemotherapy for CLDN18.2-positive metastatic stomach or gastroesophageal junction cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label Phase 2 trial comparing two dosing schedules of givastomig combined with nivolumab and chemotherapy versus nivolumab and chemotherapy alone in previously untreated, HER2-negative, CLDN18.2-positive, PD-L1-positive locally advanced or metastatic gastroesophageal adenocarcinoma. About 180 participants will be randomized 1:1:1 to two investigational arms (givastomig + nivolumab + mFOLFOX or CAPOX) or a control arm (nivolumab + chemotherapy), with chemotherapy chosen per local standard (mFOLFOX only in the US, Japan, and South Korea). Randomization is stratified by chemotherapy regimen and CLDN18.2 expression level, and tumor response will be measured by RECIST v1.1 at scheduled intervals. Safety and progression-free survival are primary focuses, with safety monitoring for tivastomig-related toxicities alongside standard adverse event reporting.

Why it matters

Who can join: the full rules

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).
* 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 Criteria:

* 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.

Where it's running

• I-Mab Site 1016
  Goodyear, Arizona, United States Recruiting
• I-MAB Site 1005
  Duarte, California, United States Recruiting
• I-Mab Site 1002
  Boston, Massachusetts, United States Recruiting
• I-Mab Site 2001
  Beijing, China Recruiting
• I-Mab Site 4005
  Tokyo, Japan Recruiting
• I-Mab Site - 4001
  Kashiwa, Japan Not yet recruiting

Study contacts

• Study coordinator: I-MAB US Clinical Trials
• Email: us.info@imabbio.com
• Phone: 301-294-4408

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.