Actively Recruiting
Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
Led by Massachusetts General Hospital · Updated on 2026-03-06
40
Participants Needed
2
Research Sites
151 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.
CONDITIONS
Official Title
Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a confirmed diagnosis of adenocarcinoma of the esophagus, gastroesophageal junction, or stomach; squamous cell tumors and HER2 positive tumors are excluded.
- Disease must be evaluable by radiographic methods, measurable or non-measurable according to RECIST version 1.1.
- No prior therapy for Stage IV disease; prior adjuvant therapy allowed if completed more than 6 months before enrollment.
- Age 18 years or older.
- ECOG Performance status of 0 to 2.
- Adequate organ and marrow function including specific blood counts, bilirubin, liver enzymes, kidney function, proteinuria, and coagulation within defined limits.
- For chronic hepatitis B, viral load must be undetectable on suppressive therapy if needed.
- Hepatitis C must be treated and cured or have undetectable viral load if on treatment.
- No active brain metastases or leptomeningeal disease; treated brain metastases with stability may be considered.
- Prior or concurrent malignancies allowed if they do not interfere with study assessments.
- Women of childbearing potential and men must agree to use effective contraception before and during study and for 9 months after last dose.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Prior treatment with PD-1 or PD-L1 inhibitors unless completed more than 6 months before enrollment.
- Major surgery or serious trauma within 4 weeks prior to enrollment or planned within 4 weeks after first dose.
- Not recovered from adverse events of prior anti-cancer therapy except mild alopecia or neuropathy.
- Receiving other investigational agents for this condition.
- History of allergic reactions to similar compounds as ivonescimab; prior oxaliplatin/5FU allergy allowed if desensitized.
- Pregnant or breastfeeding women.
- History of gastrointestinal perforation, fistula, obstruction, or extensive bowel surgery within 6 months.
- Uncontrolled hypertension despite medication.
- History of serious arterial or venous thromboembolic events within 12 months.
- Impaired wound healing history.
- History of organ transplantation.
- Uncontrolled illness or psychiatric/social conditions limiting compliance.
- Significant cardiac disease or events requiring hospitalization within 12 months.
- Use of systemic corticosteroids or immunosuppressants within 14 days before treatment.
- Active systemic infection requiring IV antibiotics within 7 days before treatment.
- HIV infection unless stable on therapy with no AIDS conditions and controlled viral load.
- History of bleeding disorders or significant bleeding risks within 4 weeks before enrollment.
- History of non-infectious pneumonitis requiring therapy within 4 weeks before registration.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UCLA
Santa Monica, California, United States, 90404
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Samuel Klempner, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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