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RECRUITING
NCT07432295
PHASE2

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

Sponsor: I-Mab Biopharma US Limited

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-02

Completion Date

2030-08

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DRUG

Givastomig

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

DRUG

Nivolumab

Q2 or Q3W IV

DRUG

5Fluorouracil

Q2W IV

DRUG

Leucovorin

Q2W IV

DRUG

Oxaliplatin

Q2W or Q3W IV

DRUG

Capecitabine

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