RecruitingPhase 2

Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)

United States, China, Japan180 participantsStarted 2026-02-11

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 significan…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-Free Survival (PFS), BICR-assessed

Timeframe: Up to 5 years

Safety and Tolerability

Timeframe: Throughout treatment and up to 30 days after last dose

Trial details

NCT IDNCT07432295

SponsorI-Mab Biopharma US Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-03

Contact for this trial

I-MAB US Clinical Trials

301-294-4408 us.info@imabbio.com

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