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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07432295.
This is a randomized, global, open-label, multicenter Phase 2 study evaluating the
efficacy and safety of givastomig (TJ033721) in combination with nivolumab and
chemotherapy compared with nivolumab and chemotherapy alone in participants with
previously untreated, HER2-negative, CLDN18.2-positive, and PD-L1-positive locally
advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (GEA).
Approximately 180 participants will be randomized in a 1:1:1 ratio to one of three
treatment arms. Two investigational arms will receive givastomig in combination with
nivolumab and chemotherapy, and the control arm will receive nivolumab and chemotherapy
alone. Chemotherapy will consist of either modified FOLFOX (mFOLFOX) or CAPOX,
administered according to local standard of care. Participants enrolled in the United
States, Japan, and South Korea will receive mFOLFOX only. Randomization will be
stratified by chemotherapy regimen (mFOLFOX vs CAPOX) and by CLDN18.2 expression level
(<75% vs ≥75% of tumor cells with membrane intensity score ≥2+).
Participants in the investigational arms will receive givastomig administered every 2
weeks or every 3 weeks, depending on the chemotherapy regimen. Tumor assessments will be
performed at protocol-defined intervals and evaluated according to Response Evaluation
Criteria in Solid Tumors (RECIST) version 1.1.
Enrollment of participants with high CLDN18.2 expression (defined as membrane intensity
score ≥1+ in ≥75% of tumor cells) will be capped at approximately 50% of the total study
population. Enrollment of participants receiving CAPOX will be capped at approximately
30% of the total study population.
Study treatment will continue until disease progression, unacceptable toxicity,
withdrawal of consent, death, or completion of study treatment, whichever occurs first.
The duration of chemotherapy treatment will follow the respective product labeling or
local standards of care.
Lead OrganizationI-Mab Biopharma Co. Ltd.
