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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: Recruiting Phase 2 study of Solid Tumor and Gastric Cancer, sponsored by I-Mab Biopharma US Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Compare PFS between participants receiving givastomig plus nivolumab and chemotherapy versus control (nivolumab plus chemotherapy)
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 |
What NCT07432295 shows while recruiting
NCT07432295 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (19% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07432295's enrollment target sits among peer trials
180 47th of 196 higher than 149 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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