RecruitingPhase 2NCT07070466

Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA

A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas


Sponsor

Massachusetts General Hospital

Enrollment

40 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called ivonescimab (which blocks both a cancer immune checkpoint and a blood vessel growth factor) combined with FOLFOX chemotherapy as a first-line treatment for advanced stomach or esophageal cancer that is HER2-negative. The goal is to see if this combination is safe and effective. **You may be eligible if...** - You have advanced adenocarcinoma of the esophagus, stomach, or the junction between them (confirmed by pathology) - Your tumor is HER2-negative (a specific protein test result) - You have not received prior chemotherapy for advanced disease **You may NOT be eligible if...** - Your tumor is HER2-positive - You have squamous cell cancer (not adenocarcinoma) - You have serious organ problems or prior treatments that conflict with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvonescimab

Humanized immunoglobulin G1 monoclonal antibody

DRUG5-Fluorouracil

Nucleoside metabolic inhibitor

DRUGOxaliplatin

Platinum-based drug and organoplatinum complex

DRUGLeucovorin

5-formyl derivative of tetrahydrofolic acid


Locations(2)

UCLA

Santa Monica, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07070466


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