NCT06846346

Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma

Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.

Detailed description

Phase 2, multicenter, two-cohort, non-randomized, open-label trial to evaluate the efficacy of ivonescimab in combination with chemotherapy in patients with advanced or metastatic gastric and esophageal adenocarcinoma, with and without actionable biomarker (HER2/PD-L1/claudin18.2).

Conditions

• Metastatic Esophageal Adenocarcinoma
• Advanced Esophageal Adenocarcinoma
• Metastatic Gastric Adenocarcinoma
• Advanced Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Ivonescimab	Ivonescimab 20 mg/kg by intravenous (IV) infusion once every 2 weeks until disease progression.
DRUG	FOLFOX regimen	Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour continuous IV infusion, every two weeks for 8 cycles followed by 5FU as maintenance therapy until disease progression.
DRUG	Irinotecan	180 mg/ m2 IV over 90 min infusion every two weeks for a minimum of 4 cycles
DRUG	Paclitaxel	80 mg/m2 IV at D1, D8 and D15, every four weeks (D1=D28)

Timeline

• Start date: 2025-11-20
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-02-26
• Last updated: 2025-11-28

Locations

4 sites across 1 country: France