GastroEsophageal CancerPhase 1NeoBEMANCT06978062
Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment
A Phase 1 study testing Bemarituzumab and FLOT in people with GastroEsophageal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GastroEsophageal Cancer
- What is being tested?
- Bemarituzumab and FLOT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 28 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)
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
- Being tested
- Bemarituzumab, FLOT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemarituzumabDrug
- Bemarituzumab will be given as a IV infusion
FLOTDrug
FLOT will be given as a IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bemarituzumab; Drug: FLOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2.3 years from first patient in
Secondary outcomes (9)
Major pathological response
Major pathological response rate will be computed as the percentage of patients who had major tumour regression (< 10% vital residual tumour cells) after neoadjuvant treatment.
Measured: 3.6 years from first patients in
Pathological complete response
Measured: 3.6 years from first patients in
Progression free survival (PFS)
Progression-free survival is defined as the time interval from enrolment to the first event of progression/recurrence
Measured: 3.6 years from first patients in
Overall survival (OS)
Overall survival will be computed from the date of enrolment to the date of death
Measured: 3.6 years from first patients in
Treatment-emergent adverse events
Measured: 3.6 years from first patients in
R0 resection
Measured: 3.6 years from first patients in
Completion rate of neoadjuvant and adjuvant therapy
Measured: 3.6 years from first patients in
Postoperative complications according to CLAVIEN DINDO classification
Measured: 3.6 years from first patients in
30 and 90 day-mortality after surgery
Measured: 1.7 years from first patients in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start20 Feb 2026 (estimated)
- Primary completion11 Sep 2028 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroEsophageal CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Markus Moehler, Principal investigator, University Medical Center MainzElizabeth Smyth, Principal investigator, University of OxfordMaike Collienne, Principal investigator, University Medical Center Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978062
- Sponsor's protocol ID
- EORTC 2385-GITCG
- Acronym
- NeoBEMA
- Status last verified
- Jun 2025
- First submitted
- 29 Apr 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)
- ClinicalTrials.gov ID
- NCT06978062
- Acronym / sponsor ID
- NeoBEMA / EORTC 2385-GITCG
- Conditions
- GastroEsophageal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 11 Sep 2028 (estimated)
- Study completion
- 28 Sep 2029 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLOT plus Bemarituzumab | Experimental | Drug: Bemarituzumab, Drug: FLOT* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bemarituzumab• Bemarituzumab will be given as a IV infusion | Drug | FLOT plus Bemarituzumab |
| FLOTFLOT will be given as a IV infusion | Drug | FLOT plus Bemarituzumab |
Primary outcome
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
Time frame: 2.3 years from first patient in
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
9 secondary outcomes
Major pathological response
Time frame: 3.6 years from first patients in
Pathological complete response
Time frame: 3.6 years from first patients in
Progression free survival (PFS)
Time frame: 3.6 years from first patients in
Overall survival (OS)
Time frame: 3.6 years from first patients in
Treatment-emergent adverse events
Time frame: 3.6 years from first patients in
R0 resection
Time frame: 3.6 years from first patients in
Completion rate of neoadjuvant and adjuvant therapy
Time frame: 3.6 years from first patients in
Postoperative complications according to CLAVIEN DINDO classification
Time frame: 3.6 years from first patients in
30 and 90 day-mortality after surgery
Time frame: 1.7 years from first patients in
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus Moehler principal investigator
University Medical Center Mainz
Elizabeth Smyth principal investigator
University of Oxford
Maike Collienne principal investigator
University Medical Center Mannheim
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bemarituzumab and FLOT in people with GastroEsophageal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EORTC EORTC (+32 27741611, eortc@eortc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2.3 years from first patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.