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NCT07432295 · ClinicalTrials.gov registry record · Phase 2
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
A Phase 2 study of Solid Tumor and Gastric Cancer, sponsored by I-Mab Biopharma US Limited.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 3
- Study locations
NCT07432295 is a Phase 2 study of Solid Tumor and Gastric Cancer that is actively recruiting participants, run by I-Mab Biopharma US Limited. The registered enrollment target is 180 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (19% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT07432295, a Phase 2 study of Solid Tumor and Gastric Cancer, is actively recruiting participants, sponsored by I-Mab Biopharma US Limited.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 3
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Nivolumab
- DRUG Givastomig
- DRUG 5Fluorouracil
Study Locations (3)
Arizona
- I-Mab Site 1016 - Goodyear
California
- I-MAB Site 1005 - Duarte
Texas
- I-Mab Site 1013 - Sugarland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2026-02 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07432295
The ClinicalTrials.gov registry entry for NCT07432295 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (19% lower). The listed sponsor is I-Mab Biopharma US Limited, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.
NCT07432295 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, California, Texas.
Frequently Asked Questions
What is clinical trial NCT07432295 about?
NCT07432295 is a clinical study titled "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 ...
What is the current status of trial NCT07432295?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2026-02. Estimated completion is 2030-08.
What conditions does trial NCT07432295 study?
This clinical trial studies the following conditions: Solid Tumor, Gastric Cancer, Advanced Cancer, Metastatic Cancer, Esophageal Adenocarcinoma.
What interventions are being tested in trial NCT07432295?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Nivolumab (DRUG), Givastomig (DRUG), 5Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT07432295?
This trial is sponsored by I-Mab Biopharma US Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07432295 being conducted?
This trial has 3 study locations across Arizona, California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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