Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment

NCT06978062 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: EORTC 2385-GITCG
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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 resectable gastroesophageal cancer. Following this neo-adjuvant part, patients should undergo surgery. Following surgery, patients will receive FLOT chemotherapy in combination with bemarituzumab. Imaging will be performed every 3 months for the first 2 years and thereafter every 6 months as per standard of care.

Conditions

GastroEsophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Completion rate of neoadjuvant treatment followed by surgery without serious anastomotic leakage, defined as the percentage of patients who completed the treatment without grade 2 or more anastomotic leakage as per Clavien-Dindo Classification

  Patients will be considered to have successfully completed the neo-adjuvant treatment if they complete the 4 cycles of FLOT plus Bemarituzumab. Additionally, anastomotic leakage will be reported as post-surgery complication following the modified Clavien-Dindo Classification

  2.3 years from first patient in

Secondary Outcomes (9)

• Major pathological response

  3.6 years from first patients in

• Pathological complete response

  3.6 years from first patients in

• Progression free survival (PFS)

  3.6 years from first patients in

• Overall survival (OS)

  3.6 years from first patients in

• Treatment-emergent adverse events

  3.6 years from first patients in

Study Arms (1)

FLOT plus Bemarituzumab

EXPERIMENTAL

* FLOT will be administered every 2 weeks (Q2W). Docetaxel 50 mg/m2 is given as 1 hour infusion, followed by Oxaliplatin 85mg/m2 as a 2-hour infusion, leucovorin 200 mg/m2 over 2 hours and 5-FU 2600 mg/m2 as a 24 hour-infusion, * Bemarituzumab will be administered as IV infusion

Drug: Bemarituzumab; Drug: FLOT

Interventions

Bemarituzumab DRUG

• Bemarituzumab will be given as a IV infusion

FLOT plus Bemarituzumab

FLOT DRUG

FLOT will be given as a IV infusion

FLOT plus Bemarituzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

MeSH Terms

Interventions

bemarituzumab

Study Officials

• Markus Moehler

  University Medical Center Mainz

  PRINCIPAL INVESTIGATOR

• Elizabeth Smyth

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Maike Collienne

  University Medical Center Mannheim

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EORTC EORTC

CONTACT

+32 27741611; eortc@eortc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 18, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): September 11, 2028
• Study Completion (Estimated): September 28, 2029
• Last Updated: June 5, 2025

Record last verified: 2025-06