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Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
Sponsor: I-Mab Biopharma US Limited
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
Conditions
Interventions
Givastomig
Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV
Nivolumab
Q2 or Q3W IV
5Fluorouracil
Q2W IV
Leucovorin
Q2W IV
Oxaliplatin
Q2W or Q3W IV
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