Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic Gastro-esophageal Adenocarcinoma FGFR2b-positive, advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction

Keywords

BEMARAFGFR2badenocarcinoma of the stomach or gastroesophageal junction

Outcome Measures

Primary Outcomes (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).
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)

Progression-free survival (PFS)
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
Overall survival (OS)
time from date of enrollment to date of death due to any cause, through study completion, up to 33 months
Disease control rate (DCR)
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
Duration of response (DoR)
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
Disease stabilization
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
+3 more secondary outcomes

Study Arms (3)

Cohort 1

EXPERIMENTAL

bemarituzumab plus SOC treatment with irinotecan

Drug: bemarituzumab, irinotecan

Cohort 2

EXPERIMENTAL

bemarituzumab plus SOC treatment with paclitaxel plus ramucirumab

Drug: bemarituzumab, paclitaxel, ramucirumab

Cohort 3

EXPERIMENTAL

bemarituzumab plus SOC treatment with trifluridine/tipiracil

Drug: bemarituzumab, trifluridine/tipiracil

Interventions

bemarituzumab, paclitaxel, ramucirumabDrug

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

Cohort 2

bemarituzumab, irinotecanDrug

Cohort 1 will receive bemarituzumab plus SOC treatment with irinotecan

Cohort 1

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
PACLITAXEL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
RAMUCIRUMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
IRINOTECAN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
Bemarituzumab
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Grouped treatment entry
bemarituzumab, paclitaxel, ramucirumab

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

PACLITAXEL
Named ingredient: Paclitaxel
View registry record
RAMUCIRUMAB
Named ingredient: Ramucirumab
View registry record
IRINOTECAN
Named ingredient: Irinotecan
View registry record
Bemarituzumab
Named ingredient: bemarituzumab
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient provide signed informed consent form.
Patient is ≥ 18 years at the time of given informed consent.

Sponsors & Collaborators

Amgen
Industrycollaborator
Johannes Gutenberg University Mainz
Othercollaborator
Technical University of Munich

Study Sites (35)

Uniklinik RWTH Aachen

Aachen, 52074, Germany

Klinikum St. Marien

Amberg, Germany

Universitätsklinikum Augsburg

Augsburg, Germany

Helios Klinikum Bad Saarow

Bad Saarow, Germany

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

Berlin, 12351, Germany

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

Berlin, 13353, Germany

VIVANTES Berlin Friedrichshain

MeSH Terms

Interventions

bemarituzumabPaclitaxelRamucirumabIrinotecanTrifluridinetipiracil

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

Sylvie Lorenzen, Prof. Dr.
Klinikum München rechts der Isar der Technischen Universität München
PRINCIPAL INVESTIGATOR
Salah Eddin Al-Batran, Prof. Dr.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 8, 2024

Study Start

March 3, 2025

Actual (reported)

Primary Completion

September 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

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.
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
+8 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (3)

Cohort 1

Cohort 2

Cohort 3

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (35)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Named ingredients in these interventions

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (3)

Cohort 1

Cohort 2

Cohort 3

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (35)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Named ingredients in these interventions

You may not qualify if:

Data Sharing

Source records

Locations