RecruitingPhase 2NCT07432295

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

A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma


Sponsor

I-Mab Biopharma US Limited

Enrollment

180 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests givastomig (a new targeted antibody) combined with nivolumab (immunotherapy) and chemotherapy as a first-line treatment for advanced stomach or oesophageal cancer that tests positive for a protein called CLDN18.2. **You may be eligible if...** - You have been diagnosed with advanced or metastatic stomach, gastroesophageal junction, or oesophageal adenocarcinoma (confirmed by biopsy) - Your tumour tests positive for CLDN18.2 and PD-L1 - You have not yet received treatment for advanced/metastatic disease (prior adjuvant therapy is allowed if finished at least 6 months ago) - You are 18 or older and in reasonably good general health **You may NOT be eligible if...** - You have already received chemotherapy or immunotherapy for metastatic disease - Your tumour does not express CLDN18.2 or PD-L1 - You have significant heart, liver, or autoimmune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGivastomig

Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV

DRUGNivolumab

Q2 or Q3W IV

DRUG5Fluorouracil

Q2W IV

DRUGLeucovorin

Q2W IV

DRUGOxaliplatin

Q2W or Q3W IV

DRUGCapecitabine

Twice daily x 14 days every 3 weeks PO


Locations(3)

I-Mab Site 1016

Goodyear, Arizona, United States

I-MAB Site 1005

Duarte, California, United States

I-Mab Site 1013

Sugarland, Texas, United States

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NCT07432295


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