Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07432295

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

Led by I-Mab Biopharma US Limited · Updated on 2026-05-14

180

Participants Needed

6

Research Sites

233 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
  • No prior treatment for advanced or metastatic disease (prior adjuvant/neoadjuvant therapy allowed if last dose was at least 6 months ago)
  • Cancer cells positive for CLDN18.2 (membrane intensity score ≥1+ on at least 1% of tumor cells)
  • Cancer cells positive for PD-L1 (combined positive score ≥1)
  • At least one measurable tumor lesion by RECIST version 1.1
  • ECOG performance status of 0 or 1
  • Adequate organ function including hematologic, hepatic, and renal parameters
  • Life expectancy of at least 90 days
  • Women of childbearing potential and men must use effective contraception during and for a defined period after the study
  • Willing and able to provide informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • HER2-positive tumors
  • Second malignancy within the past 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 the past 2 years or ongoing immunosuppressive therapy
  • Active pneumonitis or history requiring steroids or 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 central nervous system metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable)
  • Significant cardiovascular disease including NYHA Class 3-4 congestive heart failure, recent myocardial infarction, unstable angina, transient ischemic attack/stroke, or major cardiac procedures within 6 months
  • Active or uncontrolled HIV, hepatitis B or C, 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 such as DPD deficiency
  • Any other condition or laboratory abnormality that increases risk or interferes with participation as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 6 locations

1

I-Mab Site 1016

Goodyear, Arizona, United States, 85338

Actively Recruiting

2

I-MAB Site 1005

Duarte, California, United States, 91010

Actively Recruiting

3

I-Mab Site 1002

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

I-Mab Site 2001

Beijing, China

Actively Recruiting

5

I-Mab Site - 4001

Kashiwa, Japan

Not Yet Recruiting

6

I-Mab Site 4005

Tokyo, Japan

Actively Recruiting

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Research Team

I

I-MAB US Clinical Trials

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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