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AzTrials

Metastatic Gastro-esophageal AdenocarcinomaPhase 2NCT06680622

Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy

A Phase 2 study testing bemarituzumab, paclitaxel, ramucirumab, bemarituzumab, irinotecan and bemarituzumab, trifluridine/tipiracil in people with Metastatic Gastro-esophageal Adenocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 35 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate if bemarituzumab in combination with different standard of care chemotherapies enhance tumor response in patients with FGFR2b-positive advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bemarituzumab, paclitaxel, ramucirumab, bemarituzumab, irinotecan and bemarituzumab, trifluridine/tipiracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
35 sitesGermany
Study dates
3 Mar 2025to Mar 2028
Phase
Phase 2
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

  • Patient provide signed informed consent form.
  • Patient is ≥ 18 years at the time of given informed consent.
  • Patient has been diagnosed with histologically proven advanced or metastatic adenocarcinoma of the stomach or of the gastroesophageal junction, which is not amenable to potentially curative resection. Primary tumor locations will be classified following AJCC/UICC 8th ed.
  • Patient has measurable disease or non-measurable, but evaluable disease, according to RECIST v1.1
  • Patient received at least one previous line of treatment, which includes a fluoropyrimidine and a platinum, in the advanced setting or the patient has been intolerable or ineligible to fluoropyrimidine and/or platinum. Neoadjuvant/adjuvant treatment is not counted unless progression occurs <6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line of therapy.
  • Note: patient allocation to cohort 3 only if patient received at least two previous lines of treatment.
Show all 21Show fewer
  • Tumor material (archival and/or fresh) is available for centrally FGFR2b testing performed by IHC.
  • FGFR2b-selected population using 2+/3+ definition in ≥ 10% tumor cells.
  • Patients with HER2/neu-positive tumors are eligible if they received prior HER2/neu-targeted therapy.
  • Patient has an ECOG performance status ≤ 1.
  • Patient has a life expectancy > 12 weeks.
  • Patient has adequate hematological, hepatic and renal function.
  • Absolute number of neutrophils (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Hemoglobin ≥ 9 g/dL (5.58 mmol/L), without transfusion support within 7 days before the first dose of study treatment
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (or < 2 x ULN in case of liver involvement or Gilbert's disease)
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN without existing liver metastases, or ≤ 5 x ULN in the presence of liver metastases; AP ≤ 5 x ULN
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured by 24 h urine) ≥ 50 mL/min (i.e., if serum creatinine level is > 1.5 x ULN, then a 24-hour urine test must be performed to check the creatinine clearance to be determined).
  • Adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy).
  • Female patients of childbearing potential, as defined in Section 5.1.7, or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% (see Section 5.1.7) per year during the treatment period and for at least 6 months after the last trial treatment. Male patients must agree not to donate sperm within the same period. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.
  • Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Who cannot join

  • Patient received prior treatment any selective inhibitor of the FGF-FGFR pathway or participated in a study that randomized to FGFR-targeted therapy/placebo.
  • Patient has known allergic / hypersensitive reactions to at least one of the treatment components
  • Contraindication for standard of care (SOC) treatment regimen chosen by investigator (irinotecan, paclitaxel plus ramucirumab or trifluridine/tipiracil) according to specific product information or clinical standards
  • Patient has known presence of tumors other than adenocarcinomas (e.g., leiomyosarcoma, lymphoma) or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years.
  • Patient has squamous/ adenosquamous cell carcinoma of the stomach or gastroesophageal junction.
  • Patient receives simultaneous, ongoing, systemic immunotherapy, chemotherapy, hormone therapy or investigational treatment not described in the study protocol.
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  • Patient receives current treatment with any anti-cancer therapy or major surgery ≤ 2 weeks prior to study treatment start unless rapidly progressing disease is measured.
  • Patient receives simultaneous treatment with a different anti-cancer therapy (including investigational treatments) other than that provided for in the trial (excluding palliative radiotherapy for symptom control).
  • Patient has known untreated or symptomatic CNS or leptomeningeal metastases. Subjects with asymptomatic CNS metastases are eligible if clinically stable for ≥ 4 weeks and require no intervention (including use of corticosteroids). Subjects with treated brain metastases are eligible provided the following criteria are met:
  • Definitive therapy was completed at least 2 weeks prior to the first planned dose of trial treatment (stereotactic radiosurgery at least 7 days prior to first planned dose of study treatment)
  • At least 7 days prior to first dose of trial treatment: any CNS disease is clinically stable, subject is off steroids for CNS disease (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs
  • Patient has impaired cardiac function or clinically significant cardiac disease including unstable angina within 6 months before the first dose of study treatment, acute myocardial infarction < 6 months prior to the first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure > 160 mmHg or diastolic > 100 mmHg despite optimal treatment, uncontrolled cardiac arrhythmias requiring antiarrhythmic therapy other than beta blockers or digoxin, active coronary artery disease or corrected QT interval (QTc) ≥ 470
  • Patient has evidence of or any ongoing ophthalmological disorders.
  • History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroids
  • Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or are actively progressing
  • Unwillingness to avoid use of contact lenses during study treatment and for ≥ 100 days after the end of treatment
  • Recent (within 6 months) corneal surgery or ophthalmic laser treatment or recent (within 6 months) history of, or evidence of corneal defects, corneal ulcerations, keratitis, or keratoconus, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
  • Patient has a serious infection requiring oral or IV antibiotics within 14 days prior to trial enrollment.
  • Patient has an acute or chronic infection with human deficiency virus (HIV), or an acute infection with hepatitis B or C virus (HBV, HCV). Exception: Subjects with hepatitis B surface antigen or core antibodies who achieve a sustained virologic response with antiviral therapy directed against hepatitis B and subjects with hepatitis C, who achieve a sustained virologic response following antiviral therapy are permitted.
  • Patient experienced severe, life-threatening, or recurrent (Grade 2 or higher) immune-mediated adverse events (AEs) or infusion-related reactions including those that led to permanent discontinuation while on treatment with immune-oncology agents
  • Patient received prior immunosuppressive therapy: immunosuppressive doses of systemic medications of > 10 mg/day of prednisone or equivalent must be discontinued ≥ 2 weeks before the first dose of study treatment. Short courses of high dose corticosteroids and/or continuous low dose of prednisone (< 10 mg/day) are permitted. In addition, inhaled, intranasal, intraocular, and/or joint injections of corticosteroids are allowed
  • Patient has evidence of any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect.
  • Female patient is pregnant or breast feeding or planning to become pregnant within and up to 4 months after end of treatment (if enrolled to Cohort 1) or up to 6 months after the end of treatment (if enrolled to Cohort 2 or 3).

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Germany35 sites

  • Uniklinik RWTH Aachen

    Aachen, 52074

  • Klinikum St. Marien

    Amberg

  • Universitätsklinikum Augsburg

    Augsburg

  • Helios Klinikum Bad Saarow

    Bad Saarow

  • Klinikum Neukölln Vivantes Netzwerk für Gesundheit GmbH Klinlinik für Innere Medizin - Hämatologie und Onkologie

    Berlin, 12351

  • Charité - Universitätsmedizin Berlin Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK)

    Berlin, 13353

  • VIVANTES Berlin Friedrichshain

    Berlin

  • Klinikum Bielefeld gem. GmbH Klinik für Hämatologie, Onkologie und Palliativmedizin

    Bielefeld

  • Klinikum Chemnitz

    Chemnitz

  • St.-Johannes-Hospital

    Dortmund, 44137

  • Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, 01307

  • Universitätsklinikum Düsseldorf Klinik für Gastroenterologie, Hepatologie und Infektiologie Gastroonkologische Studienzentrale

    Düsseldorf, 40225

  • Kliniken Essen-Mitte

    Essen

  • Krankenhaus Nordwest GmbH Institut für Klinisch-Onkologische Forschung (IKF)

    Frankfurt

  • Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik IV; Organonkologie Studienzentrale

    Giessen, 35392

  • Universität Göttingen

    Göttingen

  • Onkodoc Gütersloh

    Gütersloh, 33332

  • Hämatologisch-Onkologische Praxis Eppendorf (hope) Norddeutsches Studienzentrum für Innovative Onkologie

    Hamburg, 20249

  • MH Hannover

    Hanover

  • Universitätsklinikum Heidelberg Nationales Centrum für Tumorerkrankungen (NCT Heidelberg)

    Heidelberg, 69120

  • St. Anna Hospital Herne

    Herne, 44649

  • Universitätsklinikum Jena

    Jena

  • Universitätsklinikum Schleswig-Holstein

    Kiel

  • Medizinisches Versorgungszentrum Landshut

    Landshut

  • Universitäres Krebszentrum Leipzig (UCCL)

    Leipzig, 04103

  • Klinikum Magdeburg

    Magdeburg

  • Universitätsmedizin Mainz I. Medizinische Klinik und Poliklinik

    Mainz, 55131

  • Klinikum rechts der Isar der technischen Univeristät München Medizinische Klinik und Poliklinik III Hämatologie und Onkologie

    München, 81675

  • Klinikum der Universität München Med. Klinik und Poliklinik III AG Onkologie

    München

  • Klinikum München-Bogenhausen

    München

  • Universitätsklinikum Regensburg

    Regensburg, 93042

  • Krankenhaus Barmherzige Brüder Regensburg Klinik für Onkologie und Hämatologie

    Regensburg, 93049

  • Kreiskliniken Reutlingen gGmbH Klinikum am Steinenberg Reutlingen/Medizinische Klinik I

    Reutlingen, 72746

  • HELIOS Kliniken Schwerin

    Schwerin

  • Klinikum Wolfsburg Medizinische Klinik II

    Wolfsburg, 38440

Other trials in Germany

About this study

Official title: Bemarituzumab in Patients With FGFR2b-positive Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy - The IKF-AIO Phase IIa BEMARA Trial

The goal of this clinical trial is to evaluate if bemarituzumab in combination with different standard of care chemotherapies enhance tumor response in patients with FGFR2b-positive advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. The main questions are:

How do patients respond to these treatments? How is the overall and the progression-free survival rate with these treatments? How is the disease control rate with these treatments? How long is the duration of response and disease stabilization with these treatments? How is the safety with these treatments? How is the quality of life with these treatments?

Read more

Patients will be allocated to one of three possible treatment cohorts according to investigator's decision and current standard of care:

Bemarituzumab with cohort 1: irinotecan cohort 2: paclitaxel plus ramucirumab cohort 3: trifluridine/tipiracil

Being tested
bemarituzumab, paclitaxel, ramucirumab, bemarituzumab, irinotecan, bemarituzumab, trifluridine/tipiracil
Keywords
BEMARA, FGFR2b, adenocarcinoma of the stomach or gastroesophageal junction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bemarituzumab, paclitaxel, ramucirumabDrug

    Cohort 2 will receive bemarituzumab plus SOC treatment with paclitaxel and ramucirumab

  • bemarituzumab, irinotecanDrug

    Cohort 1 will receive bemarituzumab plus SOC treatment with irinotecan

  • bemarituzumab, trifluridine/tipiracilDrug

    Cohort 3 will receive bemarituzumab plus SOC treatment with trifluridine/tipiracil

Study groups in NCT06680622
Study groupRoleWhat they receive
Cohort 1Experimentalbemarituzumab plus SOC treatment with irinotecan
Receives: Drug: bemarituzumab, irinotecan
Cohort 2Experimentalbemarituzumab plus SOC treatment with paclitaxel plus ramucirumab
Receives: Drug: bemarituzumab, paclitaxel, ramucirumab
Cohort 3Experimentalbemarituzumab plus SOC treatment with trifluridine/tipiracil
Receives: Drug: bemarituzumab, trifluridine/tipiracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Objective response rate (ORR), defined as proportion of subjects with a complete response (CR) or partial response (PR) acc. to RECIST v1.1, for each cohort (cohort 1 - bemarituzumab plus irinotecan, cohort 2 - bemarituzumab plus paclitaxel and ramucirumab, cohort 3 - bemarituzumab plus trifluridine/tipiracil).

    Measured: from date of enrollment to date of last response acc. to RECIST v1.1 or death due to any cause, through study completion, up to 33 months

Secondary outcomes (8)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS)

    Measured: from date of enrollment to date of progression acc. to RECIST v1.1 or death due to any cause, through study completion, up to 33 months

  2. Overall survival (OS)

    Overall survival (OS)

    Measured: time from date of enrollment to date of death due to any cause, through study completion, up to 33 months

  3. Disease control rate (DCR)

    proportion of subjects with CR, PR or stable disease (SD) according to RECIST v1.1

    Measured: time from date of enrollment to date of last tumor assessment acc. to RECIST 1.1 or death due to any cause, through study completion, up to 33 months

  4. Duration of response (DoR)

    Duration of response (DoR)

    Measured: time from response initiation (when either CR or PR is first determined) to date of progression or death to any cause, through study completion, up to 33 months

  5. Disease stabilization

    Duration of disease stabilization

    Measured: time from the first assessment of CR or PR or SD until the date of progression or death to any cause, through study completion, up to 33 months

  6. Quality of Life (QoL) with EORTC QLQ C30

    Assessment of quality of life using EORTC QLQ C30 questionnaires during treatment

    Measured: time from baseline questionnaire to last filled questionnaire in follow up or until progression or death of any cause, through study completion, up to 33 months

  7. Quality of Life (QoL) with EQ-5D-5L

    Assessment of quality of life using EQ-5D-5L visual analogue scale (VAS) score

    Measured: time from baseline questionnaire to last filled questionnaire in follow up or until progression or death of any cause, through study completion, up to 33 months

  8. Quality of Life (QoL) with HADS

    Assessment anxiety/depression and satisfaction using HADS during treatment

    Measured: time from baseline questionnaire to last filled questionnaire in follow up or until progression or death of any cause, through study completion, up to 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start3 Mar 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06680622
Sponsor's protocol ID
BEMARA
Other IDs
2024-512484-31-00
Status last verified
Jan 2026
First submitted
1 Nov 2024
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bemarituzumab, paclitaxel, ramucirumab, bemarituzumab, irinotecan and bemarituzumab, trifluridine/tipiracil in people with Metastatic Gastro-esophageal Adenocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 35 sites in Germany.

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 21 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: from date of enrollment to date of last response acc. to RECIST v1.1 or death due to any cause, through study completion, up to 33 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06680622.

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 7 Jan 2026.

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