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New drug targets Hard-to-Treat tumors in early trial

NCT ID NCT05325866

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called bemarituzumab in 260 adults with solid tumors that have high levels of a protein called FGFR2b. The main goals were to see if the drug is safe and if it can shrink tumors. Participants had already tried other treatments without success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

260 people

The number who actually took part.

Started

Sep 2022

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed 2. 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 3. Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy) 4. Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing 5. Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Adequate organ function as determined per protocol. Exclusion Criteria: 1. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease. 2. Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small cell lung cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma 3. 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 4. History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroids 5. Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing 6. Unwillingness to avoid use of contact lenses during study treatment and for at least 100 days after the end of treatment 7. 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 8. Prior treatment with any investigational selective inhibitor of the fibroblast growth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor indication).

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung Carcinoma, Ovarian Epithelial cervical carcinoma cholangiocarcinoma endometrium adenocarcinoma fallopian tube cancer head and neck squamous cell carcinoma intrahepatic cholangiocarcinoma lung adenocarcinoma ovarian carcinoma primary peritoneal carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Alexandra Hospital

    Athens, 11528, Greece

  • Ars Medical Spzoo

    Piła, 64-920, Poland

  • Asan Medical Center

    Seoul, 138-736, South Korea

  • Associacao Hospitalar Moinhos de Vento

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

  • Azienda Ospedaliera Policlinico Umberto I

    Roma, 00161, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia, 71100, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano

    Mirano, 30035, Italy

  • Beneficencia Portuguesa de Sao Paulo - Bp

    São Paulo, São Paulo, 01323-900, Brazil

  • Cabrini Hospital

    Malvern, Victoria, 3144, Australia

  • Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz

    Besançon, 25030, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centro Oncologico Korben

    Buenos Aires, 1426, Argentina

  • Centro de Infusion e Investigacion Oncologia de Saltillo

    Saltillo, Coahuila, 25279, Mexico

  • Centro de Oncologia Mackenzie

    Curitiba, Paraná, 80440-220, Brazil

  • Centrul de Oncologie Sf Nectarie SRL

    Craiova, 200347, Romania

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185, Poland

  • Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • Christus Muguerza Clinica Vidriera

    Monterrey, Nuevo León, 64570, Mexico

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Community Health Network MD Anderson Cancer Center - North

    Indianapolis, Indiana, 46250, United States

  • Complex Oncology Center Plovdiv EOOD

    Plovdiv, 4004, Bulgaria

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Docrates Syopasairaala

    Helsinki, 00180, Finland

  • European Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Fundacion Cenit Para La Investigacion

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

  • Fundacion Medica de Rio Negro y Neuquen

    Cipolletti, Río Negro Province, 8324, Argentina

  • Grand Hopital de Charleroi - Site des Viviers

    Charleroi, 6060, Belgium

  • Gustave Roussy

    Villejuif, 94805, France

  • Hadassah Ein-Kerem Medical Center

    Jerusalem, 9112001, Israel

  • Health Pharma Professional Research SA de CV

    Mexico City, Mexico City, 03100, Mexico

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hopital Lyon sud

    Pierre-Bénite, 69495, France

  • Hopitaux Universitaires de Geneve

    Geneva, 1205, Switzerland

  • Hospital Aleman

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

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010, Spain

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Galicia, 15706, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, 1900, Argentina

  • Hospital Quironsalud Barcelona

    Barcelona, Catalonia, 08023, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital da Luz, SA

    Lisbon, 1500-650, Portugal

  • Hospital das Clinicas da Ufmg

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Institut Paoli Calmettes

    Marseille, 13272, France

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059, France

  • Institut de Cancerologie de l Ouest Rene Gauducheau

    Angers, 49055, France

  • Institut regional du Cancer Montpellier

    Montpellier, 34298, France

  • Instituto Alexander Fleming

    Capital Federal, Buenos Aires, C1426ANZ, Argentina

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, São Paulo, 01221-020, Brazil

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015, Romania

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Investigacion Biomedica para el Desarrollo de Farmacos

    Mexico City, Mexico City, 03103, Mexico

  • Investigacion Onco Farmacéutica S de RL de CV

    La Paz, Baja California Sur, 23040, Mexico

  • Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS

    Candiolo to, 10060, Italy

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5000, Hungary

  • Kantonsspital Graubuenden

    Chur, 7000, Switzerland

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Masarykuv onkologicky ustav

    Brno, 656 53, Czechia

  • Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo

    Siedlce, 08-110, Poland

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Metropolitan General

    Athens, 15562, Greece

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, 1606, Bulgaria

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4000, Bulgaria

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250-905, Brazil

  • Oncologia Rede D Or

    São Paulo, São Paulo, 04501-000, Brazil

  • Orszagos Onkologiai Intezet

    Budapest, 1122, Hungary

  • Ospedale del Mare

    Naples, 80147, Italy

  • Pratia Mcm Krakow

    Krakow, 30-727, Poland

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5, Canada

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Rigshospitalet

    København Ø, 2100, Denmark

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012, United States

  • SC Oncomed SRL

    Timișoara, 300239, Romania

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Semmelweis Egyetem

    Budapest, 1082, Hungary

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Sheba Medical Center

    Ramat Gan, 5262000, Israel

  • Sociedad de Beneficencia Hospital Italiano

    Córdoba, Córdoba Province, 5000, Argentina

  • Sotiria General Hospital

    Athens, 11527, Greece

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150, Australia

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

    Nyíregyháza, 4400, Hungary

  • Tampere University Hospital

    Tampere, 33521, Finland

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75246, United States

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702, United States

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350, Australia

  • US Oncology Research Investigational Products Center

    Irving, Texas, 75063, United States

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

    Lisbon, 1440-005, Portugal

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

    Lisbon, 1649-035, Portugal

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203, United States

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • University Hospital of Heraklion

    Heraklion - Crete, 71500, Greece

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Weston Park Hospital

    Sheffield, S10 2SJ, United Kingdom

  • Wollongong Hospital

    Wollongong, New South Wales, 2500, Australia

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