NCT07070466

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single arm, open-label, non-randomized multi-institution phase II trial of the anti-PD-1 x VEGR bispecific antibody ivonoescimab in combination with standard 5-fluorouracil (5FU) and oxaliplatin as first line therapy in patients with locally advanced unresectable or metastatic HER2 negative (HER2-) gastroesophageal adenocarcinomas. The primary hypothesis is that the combination of dual VEGF and PD-1 targeting with standard 5FU/oxaliplatin (FOLFOX) will overcome intrinsic immunotherapy resistance and increase the objective response rate (ORR) and progression free survival (PFS) in frontline gastroesophageal adenocarcinomas (GEA). The goal is to determine the efficacy of this combination as measured by 6-month PFS rate and confirm the safety and tolerability in this target population.

Conditions

• Stomach Cancer Stage IV
• Esophagus Cancer
• Stomach Cancer

Interventions

Type	Name	Description
DRUG	Ivonescimab	Humanized immunoglobulin G1 monoclonal antibody
DRUG	5-Fluorouracil	Nucleoside metabolic inhibitor
DRUG	Oxaliplatin	Platinum-based drug and organoplatinum complex
DRUG	Leucovorin	5-formyl derivative of tetrahydrofolic acid

Timeline

• Start date: 2025-10-10
• Primary completion: 2026-12-01
• Completion: 2028-09-01
• First posted: 2025-07-17
• Last updated: 2026-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study