Actively Recruiting
Phase II Study Evaluating Ivonescimab Combined With Chemotherapy for First- and Second-Line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma
Led by UNICANCER · Updated on 2026-04-28
88
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. This phase 2, multicenter, non-randomized, open-label trial aims to determine whether adding ivonescimab improves the treatment response. The study includes patients with or without specific biomarkers such as HER2, PD-L1, or claudin18.2. Participants receive ivonescimab 20 mg/kg by intravenous infusion every two weeks until disease progression. The trial has two groups: one receiving FOLFOX chemotherapy combined with ivonescimab and another receiving either paclitaxel or irinotecan combined with ivonescimab per investigator choice. Treatments continue according to protocol schedules until disease progression. Participants visit the clinic every two weeks for treatments, checkups, and tests to monitor adverse events. Researchers assess tumor response using imaging, quality of life questionnaires, and track survival and progression outcomes up to three years. Safety and performance status are also monitored throughout the study and follow-up periods.
CONDITIONS
Brief Title
Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form prior to any trial specific procedures.
- Histologically or cytologically confirmed gastric cancer or esophagogastric junction adenocarcinoma.
- Metastatic or locally advanced non-resectable (stage IV) disease.
- At least one measurable lesion as assessed by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age 18 years or older.
- For patients without actionable biomarkers (HER2 and Claudin 18.2-negative except PD-L1), no prior treatment for advanced disease (cohort 1).
- For patients with at least one actionable biomarker (PD-L1 CPS≥1, HER2-positive, or Claudin 18.2-positive), who had one prior line of treatment for advanced disease (cohort 2).
- Adequate blood counts: ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL.
- Adequate kidney function: creatinine clearance or eGFR ≥50 mL/min, and urine protein less than specified limits.
- Adequate liver function: bilirubin ≤1.5× upper limit normal (ULN), AST and ALT ≤2.5× ULN (≤5× ULN if liver metastases).
- Coagulation tests within specified limits unless on stable anticoagulation.
- Women and men of childbearing potential must agree to use effective contraception during and for 120 days after treatment.
- Negative pregnancy tests for women of childbearing potential before inclusion and first dose.
- Willing and able to comply with study procedures and visits.
- Affiliation to the Social Security System or equivalent.
You will not qualify if you...
- Previous or concurrent cancer distinct from gastroesophageal cancer within 2 years, except certain treated cancers.
- Patients with high microsatellite instability (MSI-H) or mismatch repair deficiency tumors.
- Enteral intake less than 1500 kcal/day or weight loss over 15% in 6 months.
- Unresolved toxicities from prior treatments above grade 1, except alopecia.
- Major surgery or serious trauma within 4 weeks before treatment or planned within 4 weeks after first dose.
- History of bleeding tendencies, significant bleeding symptoms, or unstable anticoagulation.
- Poorly controlled hypertension after medication.
- Significant heart or vascular diseases within specified times before inclusion.
- Recent gastrointestinal complications or surgeries within specified time frames.
- Imaging showing major blood vessel invasion, tumor cavitation, or higher bleeding risk.
- Immunosuppressive therapy longer than 7 days within 14 days before study therapy.
- Active autoimmune disease requiring systemic treatment in past 2 years, with exceptions.
- Prior bone marrow or solid organ transplantation.
- Known interstitial lung disease.
- Uncontrolled HIV infection.
- Chronic hepatitis B or C infection.
- Deficiency of dihydropyrimidine dehydrogenase if fluorouracil treatment planned.
- Any condition making participation undesirable or jeopardizing compliance.
- Pregnant or breastfeeding women.
- Participation in another therapeutic trial within 30 days before enrollment.
- Unwilling or unable to comply with study follow-up due to personal reasons.
- Individuals under protective custody or guardianship.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or discontinuation
Participants receive ivonescimab combined with chemotherapy as first- or second-line treatment for advanced or metastatic gastric or gastroesophageal adenocarcinoma.
Intravenous infusions every 2 weeks; chemotherapy cycles vary by regimen (up to 8 cycles for FOLFOX, minimum 4 cycles for irinotecan, or weekly for paclitaxel)
Trial Site Locations
Total: 4 locations
1
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
2
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
3
Institut Jean Godinot
Reims, France, 51100
Actively Recruiting
4
Institut de Cancerologie de l'Ouest - Site René Gauducheau
Saint-Herblain, France
Not Yet Recruiting
Research Team
N
Nicolas DE SOUSA CARVALHO
L
Laure MONARD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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