RecruitingPhase 2NCT06846346

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

Sponsor

UNICANCER

Enrollment

88 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called ivonescimab combined with chemotherapy in people with advanced or metastatic gastric cancer (stomach cancer) or cancer where the stomach meets the esophagus, to see if this combination is more effective than existing treatments. **You may be eligible if...** - You have confirmed advanced or metastatic stomach cancer or gastroesophageal junction cancer - Your cancer is measurable on imaging scans - You have not previously received chemotherapy for advanced disease, or have received limited prior treatment (depending on the study arm) **You may NOT be eligible if...** - You have had extensive prior chemotherapy for this cancer - You have active autoimmune disease - You have uncontrolled brain metastases - You have serious heart or organ problems - You are pregnant or breastfeeding 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

Ivonescimab 20 mg/kg by intravenous (IV) infusion once every 2 weeks until disease progression.

DRUGFOLFOX 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.

DRUGIrinotecan

180 mg/ m2 IV over 90 min infusion every two weeks for a minimum of 4 cycles

DRUGPaclitaxel

80 mg/m2 IV at D1, D8 and D15, every four weeks (D1=D28)