Status:
NOT_YET_RECRUITING
Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
GastroEsophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label,multi-centre, phase 1b safety and feasibility study aiming to assess the safey and feasibility of bemarituzumab plus chemiotherapy (FLOT) for the peri-operative treatment of rese...
Eligibility Criteria
Inclusion
- Signed screening informed consent
- Age ≥ 18 years
- Availability of a diagnostic tumour sample for central evaluation (FFPE block or minimum 10 slides).
- Histologically proven, previously untreated, locally advanced, resectable gastric/GEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0. Note: if the results of the staging laparoscopy are pending at this stage it is acceptable to include the patients in this step, in the interest of patient time-to-treatment.
- Planned peri-operative treatment with FLOT chemotherapy and surgically assessed feasible R0 resection
- Centrally confirmed FGFR2b overexpression as defined by ≥10% tumour cells with 2+/3+ FGFR2b staining by immunohistochemistry (IHC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Previously untreated, locally advanced, histologically confirmed, resectable gastric/GEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0 by radiological and surgical staging
- Adequate hematologic and organ function
Exclusion
- Prior anticancer treatment for the disease under investigation
- History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmologic corticosteroids
- Evidence of any ongoing ophthalmologic abnormalities or symptoms that are recent (within 4weeks) or actively progressing
- Unwillingness to avoid the use of contact lenses during study treatment and follow-up period of at least 100 days after end of treatment.
- Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmologic laser treatment
- History of solid organ transplantation
- History of interstitial lung disease
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
- Patients on immunosuppressive therapy or having immune system disorders, including auto-immune diseases. Concurrent steroid use of not more than an equivalent of 10 mg/day prednisolone is allowed. Inhaled, intranasal, intraocular, and/or joint injections of corticosteroids are allowed.
Key Trial Info
Start Date :
February 20 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 28 2029
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06978062
Start Date
February 20 2026
End Date
September 28 2029
Last Update
June 5 2025
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