Actively Recruiting
Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma
Led by UNICANCER · Updated on 2026-04-28
88
Participants Needed
4
Research Sites
145 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 written informed consent before any trial procedures
- Histologically or cytologically confirmed gastric or esophagogastric junction adenocarcinoma
- Metastatic or locally advanced non-resectable (stage IV) disease
- At least one measurable lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age 18 years or older
- No prior advanced disease treatment for patients without actionable biomarkers (cohort 1)
- One prior line of treatment for patients with actionable biomarkers (cohort 2)
- Adequate blood counts and organ function as specified
- Women of childbearing potential and unsterilized males must agree to use effective contraception
- Negative pregnancy tests for women of childbearing potential
- Willing and able to comply with study procedures and visits
- Affiliated to Social Security System or equivalent
You will not qualify if you...
- Previous or concurrent cancer distinct from gastroesophageal cancer within 2 years (with exceptions)
- High microsatellite instability (MSI-H) or mismatched repair disease (dMMR) tumor
- Enteral intake below 1500 kcal/day or weight loss over 15% in last 6 months
- Unresolved toxicities from previous treatments above grade 1 (except alopecia)
- Major surgery or serious trauma within 4 weeks before treatment start
- History of bleeding risks or unstable anticoagulation
- Poorly controlled high blood pressure
- Recent serious heart, lung, or gastrointestinal conditions
- Radiological evidence of major blood vessel invasion or tumor cavitation
- Recent use of immunosuppressive therapy beyond 7 days
- 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 without recent testing
- Complete deficiency of dihydropyrimidine dehydrogenase if fluorouracil planned
- Conditions making participation unsafe or non-compliant
- Pregnant or breastfeeding women
- Participation in another therapeutic trial within 30 days
- Unwilling or unable to comply with follow-up
- Individuals under custody or protective guardianship
AI-Screening
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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
CONTACT
L
Laure MONARD
CONTACT
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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