Study on Givastomig with Nivolumab and Chemotherapy for Adults with CLDN18.2 Positive Metastatic Stomach Cancer

Sponsor: I-Mab Biopharma US Limited

Sponsor score: 0

ClinicalTrials ID:NCT07432295

Provider View

This clinical trial is testing whether adding the drug givastomig to standard treatment can help treat adults with stomach or esophagus cancer that has spread. The study will also look at the safety of givastomig and how it affects the time patients live without their cancer getting worse.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding givastomig to standard treatment, which includes the immunotherapy drug nivolumab and chemotherapy, can help treat adults with advanced stomach or esophagus cancer that cannot be removed by surgery. The study will also assess the safety of givastomig and monitor any side effects. Participants must have cancer cells that express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1, but not HER2. Up to 180 participants will be randomly assigned to receive either givastomig with nivolumab and chemotherapy or nivolumab and chemotherapy alone. Treatments will be given through an IV every 2 or 3 weeks. Participants will visit the study center regularly for treatments, check-ups, and scans to monitor their cancer.

Description

This study involves testing a new treatment combination for adults with advanced stomach or esophagus cancer. Participants will be randomly assigned to one of three groups: two groups will receive the new drug givastomig along with nivolumab and chemotherapy, while the third group will receive only nivolumab and chemotherapy. The chemotherapy will be either mFOLFOX or CAPOX, depending on the location. Participants in the U.S., Japan, and South Korea will receive mFOLFOX only. The study will monitor how well the cancer responds to the treatment and any side effects. Participants will continue treatment until their cancer progresses, they experience unacceptable side effects, they choose to stop, or the study ends. The study will also limit the number of participants with high levels of CLDN18.2 expression and those receiving CAPOX chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic stomach, gastroesophageal junction, or esophageal cancer that cannot be removed by surgery.
  • Have not received treatment for advanced/metastatic cancer before (previous treatment allowed if it was more than 6 months ago).
  • Cancer cells must express CLDN18.2 and PD-L1 proteins.
  • Have at least one measurable tumor.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate organ function, including specific blood cell counts and liver and kidney function.
  • Have a life expectancy of at least 90 days.
  • Agree to use effective birth control during the study and for a specified time after treatment.
  • Be willing to provide informed consent and follow study procedures.

Exclusion Criteria

  • Have HER2-positive tumors.
  • Have had another cancer within the last 3 years, except for certain skin or cervical cancers.
  • Have active or unstable stomach ulcers or bleeding within the last 6 weeks.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have active lung inflammation or a history of it requiring treatment in the past 3 years.
  • Be participating in another clinical trial.
  • Have had major surgery or a significant injury within the last 4 weeks, or plan to have major surgery within 6 months.
  • Have received radiotherapy recently without adequate recovery.
  • Have active brain metastases or cancer in the brain lining (treated brain metastases allowed if stable).
  • Have significant heart disease or recent heart events.
  • Have active or uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Have received a live vaccine within 30 days or other vaccines within 7 days of starting the study.
  • Have an active infection requiring IV treatment.
  • Have known allergies to study drug components.
  • Have any other condition that increases risk or interferes with the study.

Locations

FACILITYZIPCITYSTATE
I-Mab Site 101685338GoodyearArizona
I-MAB Site 100591010DuarteCalifornia
I-Mab Site 100202114BostonMassachusetts

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.