A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

NCT05325866 | Completed Phase 1 FDA Drug

• 2 other identifiers: 202101042023-505455-44
• Study Type: interventional
• Target: 260
• Locations: 25 countries
• Sites: 109

Brief Summary

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

Conditions

Solid Tumors

Keywords

Epithelial solid tumors with fibroblast growth factor receptor 2b overexpression; FGFR2b; Head and neck squamous cell carcinoma; Triple-negative breast cancer; Intrahepatic cholangiocarcinoma; Lung adenocarcinoma; Ovarian epithelial carcinoma; Endometrial adenocarcinoma; Cervical carcinoma; Bemarituzumab; AMG 552; Other solid tumors

Outcome Measures

Primary Outcomes (4)

• 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)

  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.

  Day 1 to 28 days after last dose (a maximum of 2 years)

• 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

  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).

  Up to approximately 2 years

Secondary Outcomes (11)

• Part 1: OR Rate

  Up to approximately 2 years

• Parts 1 and 2: Disease Control (DC) Rate

  Up to approximately 2 years

• Parts 1 and 2: Duration of Response (DOR)

  Up to approximately 2 years

• 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

Study Arms (2)

Part 1: Monotherapy Dose Exploration

EXPERIMENTAL

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.

Drug: Bemarituzumab

Part 2: Monotherapy Dose Expansion

EXPERIMENTAL

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.

Drug: Bemarituzumab

Interventions

Bemarituzumab DRUG

Intravenous (IV) infusion.

Also known as: AMG 552

Part 1: Monotherapy Dose Exploration; Part 2: Monotherapy Dose Expansion

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (115)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012, United States

Location

Community Health Network MD Anderson Cancer Center - North

Indianapolis, Indiana, 46250, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - Dallas Fort Worth

Dallas, Texas, 75246, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

US Oncology Research Investigational Products Center

Irving, Texas, 75063, United States

Location

Texas Oncology Northeast Texas

Tyler, Texas, 75702, United States

Location

Instituto Alexander Fleming

Capital Federal, Buenos Aires, C1426ANZ, Argentina

Location

Hospital Aleman

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

Location

Fundacion Cenit Para La Investigacion

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1125ABD, Argentina

Location

Hospital Italiano de La Plata

La Plata, Buenos Aires, 1900, Argentina

Location

Sociedad de Beneficencia Hospital Italiano

Córdoba, Córdoba Province, 5000, Argentina

Location

Fundacion Medica de Rio Negro y Neuquen

Cipolletti, Río Negro Province, 8324, Argentina

Location

Centro Oncologico Korben

Buenos Aires, 1426, Argentina

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

Location

Toowoomba Hospital

Toowoomba, Queensland, 4350, Australia

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

St John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

Location

Medizinische Universitaet Graz

Graz, 8036, Austria

Location

Landeskrankenhaus Salzburg

Salzburg, 5020, Austria

Location

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Grand Hopital de Charleroi - Site des Viviers

Charleroi, 6060, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Hospital das Clinicas da Ufmg

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Centro de Oncologia Mackenzie

Curitiba, Paraná, 80440-220, Brazil

Location

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, São Paulo, 01221-020, Brazil

Location

Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo, 01323-900, Brazil

Location

Oncologia Rede D Or

São Paulo, São Paulo, 04501-000, Brazil

Location

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, 22250-905, Brazil

Location

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, 4000, Bulgaria

Location

Complex Oncology Center Plovdiv EOOD

Plovdiv, 4004, Bulgaria

Location

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, 1606, Bulgaria

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

Location

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Rigshospitalet

København Ø, 2100, Denmark

Location

Docrates Syopasairaala

Helsinki, 00180, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Institut de Cancerologie de l Ouest Rene Gauducheau

Angers, 49055, France

Location

Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Institut Paoli Calmettes

Marseille, 13272, France

Location

Institut regional du Cancer Montpellier

Montpellier, 34298, France

Location

Hopital Lyon sud

Pierre-Bénite, 69495, France

Location

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31059, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Sotiria General Hospital

Athens, 11527, Greece

Location

Alexandra Hospital

Athens, 11528, Greece

Location

Metropolitan General

Athens, 15562, Greece

Location

University Hospital of Heraklion

Heraklion - Crete, 71500, Greece

Location

European Interbalkan Medical Center

Thessaloniki, 57001, Greece

Location

Semmelweis Egyetem

Budapest, 1082, Hungary

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

Nyíregyháza, 4400, Hungary

Location

Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, 5000, Hungary

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Hadassah Ein-Kerem Medical Center

Jerusalem, 9112001, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS

Candiolo to, 10060, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, 71100, Italy

Location

Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano

Mirano, 30035, Italy

Location

Ospedale del Mare

Naples, 80147, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Azienda Ospedaliera Policlinico Umberto I

Roma, 00161, Italy

Location

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550, Japan

Location

Investigacion Onco Farmacéutica S de RL de CV

La Paz, Baja California Sur, 23040, Mexico

Location

Centro de Infusion e Investigacion Oncologia de Saltillo

Saltillo, Coahuila, 25279, Mexico

Location

Health Pharma Professional Research SA de CV

Mexico City, Mexico City, 03100, Mexico

Location

Investigacion Biomedica para el Desarrollo de Farmacos

Mexico City, Mexico City, 03103, Mexico

Location

Christus Muguerza Clinica Vidriera

Monterrey, Nuevo León, 64570, Mexico

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA, Netherlands

Location

Pratia Mcm Krakow

Krakow, 30-727, Poland

Location

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338, Poland

Location

Ars Medical Spzoo

Piła, 64-920, Poland

Location

Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo

Siedlce, 08-110, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60-185, Poland

Location

Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier

Lisbon, 1440-005, Portugal

Location

Hospital da Luz, SA

Lisbon, 1500-650, Portugal

Location

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

Centrul de Oncologie Sf Nectarie SRL

Craiova, 200347, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

SC Oncomed SRL

Timișoara, 300239, Romania

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, Catalonia, 08023, Spain

Location

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1205, Switzerland

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Triple Negative Breast Neoplasms; Cholangiocarcinoma; Adenocarcinoma of Lung; Carcinoma, Ovarian Epithelial; Uterine Cervical Neoplasms

Interventions

bemarituzumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: September 23, 2022
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

AU (2); IT (6); JP (5); US (10); BR (7); PT (3); AR (7); BU (3); GR (5); FR (8); NL (2); PL (5); ES (5); CH (2); CA (3); GB (2); ME (5); CZ (4); DK (1); BE (5); RO (4); HU (4); FI (2); IL (5); KR (4)