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

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

Trial Details

NCT ID

NCT07432295

Phase

PHASE2

Sponsor

I-Mab Biopharma US Limited

Status

RECRUITING

Cancer Type

Adenocarcinoma Esophageal Cancer

Interventions

Givastomig
Nivolumab
5Fluorouracil
Leucovorin
Oxaliplatin
Capecitabine

Locations (sample)

Goodyear, Arizona, United States|33.43532,-112.35821
Duarte, California, United States|34.13945,-117.97729
Boston, Massachusetts, United States|42.35843,-71.05977
Beijing, China|39.9075,116.39723
Kashiwa, Japan|35.86224,139.97732

Key Eligibility Criteria

Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).
Treatment-naïve for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy allowed if ≥6 months since last dose).
CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).
PD-L1 positive (CPS ≥1).

For full eligibility, visit ClinicalTrials.gov.

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