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

Sponsor
UNICANCER
Study ID
NCT06846346
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    Ivonescimab 20 mg/kg by intravenous (IV) infusion once every 2 weeks until disease progression.
  • FOLFOX regimen — DRUG
    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.
  • Irinotecan — DRUG
    180 mg/ m2 IV over 90 min infusion every two weeks for a minimum of 4 cycles
  • Paclitaxel — DRUG
    80 mg/m2 IV at D1, D8 and D15, every four weeks (D1=D28)

Study Details

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.

Key Dates

Start date
Nov 20, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
88 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1st line
    FOLFOX combined with Ivonescimab
  • Experimental: 2nd line
    Paclitaxel or Irinotecan (at investigator discretion) combined with ivonescimab

Primary Outcome Measure

Objective Response Rate assessed by central review [ Time Frame: Time from inclusion to disease progression, up to 3 years ]

Central Contacts

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