A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
- Registration Number
- NCT05325866
- Lead Sponsor
- Amgen
- Brief Summary
The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 260
-
Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed
-
Histologically or cytologically confirmed cancer of one of the following types, refractory to or relapsed after at least 1 prior standard therapeutic regimen in the advanced/metastatic setting, as specified below. If no standard of care therapies exist for the participant, or the participant cannot tolerate or refuses standard of care anticancer therapy, the participant may be allowed to participate on the study after discussion between the investigator and Amgen medical monitor. Participants who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving bemarituzumab are available prior to consenting to participate in the trial.
- head and neck squamous cell carcinoma: ≥ 1 line of therapy
- triple-negative breast cancer: ≥ 2 lines of therapy
- Intrahepatic cholangiocarcinoma ≥ 1 line of therapy
- lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor, and targeted therapy
- platinum resistant ovarian epithelial cell carcinoma, including fallopian tube cancers and primary peritoneal cancers, defined as progression during or within 6 months of a platinum containing regimen: ≥ 1 line of therapy
- endometrial adenocarcinoma: ≥ 1 line of therapy
- cervical carcinoma: ≥ 1 line of therapy
- other solid tumors: ≥ 1 line of therapy
-
Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
-
Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing
-
Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-
Adequate organ function as determined per protocol.
- Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small cell lung cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma
- Impaired cardiac function or clinically significant cardiac disease including: unstable angina within 6 months prior to first dose of study treatment, acute myocardial infarction ≥ 6 months prior to 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 anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease or corrected QT interval QTc ≥ 470
- 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 actively progressing
- Unwillingness to avoid use of contact lenses during study treatment and for at least 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 prior/concomitant therapy
- Prior treatment with any investigational selective inhibitor of the fibroblast growth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor indication).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Monotherapy Dose Exploration Bemarituzumab Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive 1 of 2 dose regimens of bemarituzumab to determine recommended Phase 2 dose. Part 2: Monotherapy Dose Expansion Bemarituzumab Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive the dose of bemarituzumab identified as the recommended Phase 2 dose during Part 1.
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) Day 1 to Day 28 Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) Day 1 to 28 days after last dose (a maximum of 2 years) Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.
Part 1: Number of Participants Who Experience a Treatment-related Adverse Event Day 1 to 28 days after last dose (a maximum of 2 years) Part 2: Objective Response (OR) Rate Up to approximately 2 years OR = complete response (CR) + partial response (PR), measured by computed tomography (CT) or magnetic resonance imaging (MRI) as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Secondary Outcome Measures
Name Time Method Part 1: OR Rate Up to approximately 2 years OR = CR + PR, measured by CT or MRI as determined by investigator per RECIST v1.1.
Parts 1 and 2: Disease Control (DC) Rate Up to approximately 2 years DC = CR, PR, or stable disease (SD).
Parts 1 and 2: Duration of Response (DOR) Up to approximately 2 years DOR, defined as the time from first documentation of OR (as determined by investigator per RECIST v1.1) until the first documentation of disease progression or death due to any cause, whichever occurs first. Only participants who have achieved OR will be evaluated for DOR. DOR will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy.
Parts 1 and 2: Time to Response Up to approximately 2 years Parts 1 and 2: Progression-free Survival (PFS) Up to approximately 2 years PFS, defined as time from first dose of investigational product until the first documentation of radiologic disease progression or death due to any cause. PFS will be censored at the last evaluable post-baseline tumor assessment prior to subsequent therapy. Progression will be based on RECIST v1.1 (derived utilizing investigator tumor assessments).
Parts 1 and 2: Overall Survival (OS) Up to approximately 2 years OS, defined as time from first dose of investigational product until death from any cause. Participants still alive will be censored at the date last known to be alive.
Part 2: Number of Participants Who Experience a TEAE Day 1 to 28 days after last dose (a maximum of 2 years) AEs are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.
Part 2: Number of Participants Who Experience a Treatment-related AE Day 1 to 28 days after last dose (a maximum of 2 years) Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab Day 1 to 28 days after last dose (a maximum of 2 years) Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab Day 1 to 28 days after last dose (a maximum of 2 years) Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab Day 1 to 28 days after last dose (a maximum of 2 years)
Trial Locations
- Locations (115)
Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
Gustave Roussy
🇫🇷Villejuif, France
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Oncoclinicas Rio de Janeiro S A
🇧🇷Rio de Janeiro, Brazil
Institut Paoli Calmettes
🇫🇷Marseille Cedex 09, France
Sotiria General Hospital
🇬🇷Athens, Greece
European Interbalkan Medical Center
🇬🇷Thessaloniki, Greece
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Medizinische Universitaet Graz
🇦🇹Graz, Austria
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of California Irvine
🇺🇸Orange, California, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
Community Health Network MD Anderson Cancer Center - North
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
United States Oncology Regulatory Affairs Corporate Office
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Dallas Fort Worth
🇺🇸Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
US Oncology Research Investigational Products Center
🇺🇸Irving, Texas, United States
Texas Oncology Northeast Texas
🇺🇸Tyler, Texas, United States
Instituto Alexander Fleming
🇦🇷Capital Federal, Buenos Aires, Argentina
Hospital Aleman
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Fundacion Cenit Para La Investigacion
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de La Plata
🇦🇷La Plata, Buenos Aires, Argentina
Sociedad de Beneficencia Hospital Italiano
🇦🇷Cordoba, Córdoba, Argentina
Fundacion Medica de Rio Negro y Neuquen
🇦🇷Cipolletti, Río Negro, Argentina
Centro Oncologico Korben
🇦🇷Buenos Aires, Argentina
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Wollongong Hospital
🇦🇺Wollongong, New South Wales, Australia
Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
St John of God Murdoch Hospital
🇦🇺Murdoch, Western Australia, Australia
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Belgium
Grand Hopital de Charleroi - Site des Viviers
🇧🇪Charleroi, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Hospital das Clinicas da Ufmg
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Centro de Oncologia Mackenzie
🇧🇷Curitiba, Paraná, Brazil
Associacao Hospitalar Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
🇧🇷Sao Paulo, São Paulo, Brazil
Beneficencia Portuguesa de Sao Paulo - Bp
🇧🇷Sao Paulo, São Paulo, Brazil
Oncologia Rede D Or
🇧🇷Sao Paulo, São Paulo, Brazil
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
🇧🇬Plovdiv, Bulgaria
Complex Oncology Center Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
🇧🇬Sofia, Bulgaria
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Rigshospitalet
🇩🇰Kobenhavn O, Denmark
Docrates Syopasairaala
🇫🇮Helsinki, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Institut de Cancerologie de l Ouest Rene Gauducheau
🇫🇷Angers Cedex 02, France
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Centre Oscar Lambret
🇫🇷Lille Cedex, France
Institut regional du Cancer Montpellier
🇫🇷Montpellier Cedex 5, France
Hopital Lyon sud
🇫🇷Pierre-Benite, France
Institut Universitaire du Cancer Toulouse Oncopole
🇫🇷Toulouse cedex 9, France
Alexandra Hospital
🇬🇷Athens, Greece
Metropolitan General
🇬🇷Athens, Greece
University Hospital of Heraklion
🇬🇷Heraklion - Crete, Greece
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
🇭🇺Nyiregyhaza, Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
🇭🇺Szolnok, Hungary
Rambam Medical Center
🇮🇱Haifa, Israel
Hadassah Ein-Kerem Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
🇮🇹Candiolo TO, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
🇮🇹Foggia, Italy
Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano
🇮🇹Mirano, Italy
Ospedale del Mare
🇮🇹Napoli, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Azienda Ospedaliera Policlinico Umberto I
🇮🇹Roma, Italy
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Investigacion Onco Farmacéutica S de RL de CV
🇲🇽La Paz, Baja California Sur, Mexico
Centro de Infusion e Investigacion Oncologia de Saltillo
🇲🇽Saltillo, Coahuila, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos
🇲🇽Ciudad de Mexico, Distrito Federal, Mexico
Health Pharma Professional Research SA de CV
🇲🇽Mexico City, Distrito Federal, Mexico
Christus Muguerza Clinica Vidriera
🇲🇽Monterrey, Nuevo León, Mexico
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Netherlands
Pratia Mcm Krakow
🇵🇱Krakow, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Ars Medical Spzoo
🇵🇱Pila, Poland
Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
🇵🇱Siedlce, Poland
Centrum Medyczne Pratia Poznan
🇵🇱Skorzewo, Poland
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
🇵🇹Lisboa, Portugal
Hospital da Luz, SA
🇵🇹Lisboa, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
🇷🇴Cluj Napoca, Romania
Centrul de Oncologie Sf Nectarie SRL
🇷🇴Craiova, Romania
Institutul Regional de Oncologie Iasi
🇷🇴Iasi, Romania
SC Oncomed SRL
🇷🇴Timisoara, Romania
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucía, Spain
Hospital Quironsalud Barcelona
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Galicia, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hopitaux Universitaires de Geneve
🇨🇭Geneve 14, Switzerland
Christie Hospital
🇬🇧Manchester, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, United Kingdom