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

NCT07432295 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-14

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

  • I-Mab Biopharma US Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-11
Primary Completion
2030-03-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States
  • China
  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07432295 on ClinicalTrials.gov