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Solid TumorsPhase 1/2FORTITUDE-301NCT05325866

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

A Phase 1/2 study testing Bemarituzumab in people with Solid Tumors, run by Amgen at 115 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Solid Tumors
What is being tested?
Bemarituzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
115 sitesin 26 countries
Study dates
23 Sep 2022to 28 Jan 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

115 sites in 26 countries.

115 sites in 26 countries

United States10 sites

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75246

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope National Medical Center

    Duarte, California, 91010

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Community Health Network MD Anderson Cancer Center - North

    Indianapolis, Indiana, 46250

  • US Oncology Research Investigational Products Center

    Irving, Texas, 75063

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203

  • University of California Irvine

    Orange, California, 92868

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702

Other trials in United States

France8 sites

  • Institut de Cancerologie de l Ouest Rene Gauducheau

    Angers, 49055

  • Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Centre Oscar Lambret

    Lille, 59020

  • Institut Paoli Calmettes

    Marseille, 13272

  • Institut regional du Cancer Montpellier

    Montpellier, 34298

  • Hopital Lyon sud

    Pierre-Bénite, 69495

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Argentina7 sites

  • Centro Oncologico Korben

    Buenos Aires, 1426

  • Instituto Alexander Fleming

    Capital Federal, Buenos Aires, C1426ANZ

  • Fundacion Medica de Rio Negro y Neuquen

    Cipolletti, Río Negro Province, 8324

  • Hospital Aleman

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT

  • Fundacion Cenit Para La Investigacion

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1125ABD

  • Sociedad de Beneficencia Hospital Italiano

    Córdoba, Córdoba Province, 5000

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, 1900

Other trials in Argentina

Brazil7 sites

  • Hospital das Clinicas da Ufmg

    Belo Horizonte, Minas Gerais, 30130-100

  • Centro de Oncologia Mackenzie

    Curitiba, Paraná, 80440-220

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250-905

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, São Paulo, 01221-020

  • Beneficencia Portuguesa de Sao Paulo - Bp

    São Paulo, São Paulo, 01323-900

  • Oncologia Rede D Or

    São Paulo, São Paulo, 04501-000

Other trials in Brazil

Australia6 sites

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

Italy6 sites

  • Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS

    Candiolo to, 10060

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia, 71100

  • Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano

    Mirano, 30035

  • Ospedale del Mare

    Naples, 80147

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Azienda Ospedaliera Policlinico Umberto I

    Roma, 00161

Other trials in Italy

Belgium5 sites

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Grand Hopital de Charleroi - Site des Viviers

    Charleroi, 6060

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Greece5 sites

  • Sotiria General Hospital

    Athens, 11527

  • Alexandra Hospital

    Athens, 11528

  • Metropolitan General

    Athens, 15562

  • University Hospital of Heraklion

    Heraklion - Crete, 71500

  • European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

Israel5 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Hadassah Ein-Kerem Medical Center

    Jerusalem, 9112001

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5262000

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Japan5 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

Other trials in Japan

Mexico5 sites

  • Investigacion Onco Farmacéutica S de RL de CV

    La Paz, Baja California Sur, 23040

  • Health Pharma Professional Research SA de CV

    Mexico City, Mexico City, 03100

  • Investigacion Biomedica para el Desarrollo de Farmacos

    Mexico City, Mexico City, 03103

  • Christus Muguerza Clinica Vidriera

    Monterrey, Nuevo León, 64570

  • Centro de Infusion e Investigacion Oncologia de Saltillo

    Saltillo, Coahuila, 25279

Other trials in Mexico

Poland5 sites

  • Pratia Mcm Krakow

    Krakow, 30-727

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Ars Medical Spzoo

    Piła, 64-920

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

    Siedlce, 08-110

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185

Other trials in Poland

Spain5 sites

  • Hospital Quironsalud Barcelona

    Barcelona, Catalonia, 08023

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Galicia, 15706

Other trials in Spain

Czechia4 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

Other trials in Czechia

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1082

  • Orszagos Onkologiai Intezet

    Budapest, 1122

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

    Nyíregyháza, 4400

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

    Szolnok, 5000

Other trials in Hungary

Romania4 sites

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sf Nectarie SRL

    Craiova, 200347

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • SC Oncomed SRL

    Timișoara, 300239

Other trials in Romania

South Korea4 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Bulgaria3 sites

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4000

  • Complex Oncology Center Plovdiv EOOD

    Plovdiv, 4004

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, 1606

Other trials in Bulgaria

Canada3 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Portugal3 sites

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

    Lisbon, 1440-005

  • Hospital da Luz, SA

    Lisbon, 1500-650

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

    Lisbon, 1649-035

Other trials in Portugal

Austria2 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

Other trials in Austria

Finland2 sites

  • Docrates Syopasairaala

    Helsinki, 00180

  • Tampere University Hospital

    Tampere, 33521

Other trials in Finland

Netherlands2 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

Other trials in Netherlands

Switzerland2 sites

  • Kantonsspital Graubuenden

    Chur, 7000

  • Hopitaux Universitaires de Geneve

    Geneva, 1205

Other trials in Switzerland

United Kingdom2 sites

  • Christie Hospital

    Manchester, M20 4BX

  • Weston Park Hospital

    Sheffield, S10 2SJ

Other trials in United Kingdom

Denmark1 site

  • Rigshospitalet

    København Ø, 2100

Other trials in Denmark

About this study

Official title: A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)

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

Conditions
Solid Tumors
Being tested
Bemarituzumab
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
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms, Cholangiocarcinoma, Adenocarcinoma of Lung, Carcinoma, Ovarian Epithelial, Uterine Cervical Neoplasms

What participants receive

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

  • BemarituzumabDrug

    Also called AMG 552

    Intravenous (IV) infusion.

Study groups in NCT05325866
Study groupRoleWhat they receive
Part 1: Monotherapy Dose ExplorationExperimentalParticipants 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.
Receives: Drug: Bemarituzumab
Part 2: Monotherapy Dose ExpansionExperimentalParticipants 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.
Receives: Drug: Bemarituzumab

What is being measured

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

  1. Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

    Measured: Day 1 to Day 28

  2. 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.

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

  3. Part 1: Number of Participants Who Experience a Treatment-related Adverse Event

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

  4. 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).

    Measured: Up to approximately 2 years

Secondary outcomes (11)

  1. Part 1: OR Rate

    OR = CR + PR, measured by CT or MRI as determined by investigator per RECIST v1.1.

    Measured: Up to approximately 2 years

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

    DC = CR, PR, or stable disease (SD).

    Measured: Up to approximately 2 years

  3. Parts 1 and 2: Duration of Response (DOR)

    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.

    Measured: Up to approximately 2 years

  4. Parts 1 and 2: Time to Response

    Measured: Up to approximately 2 years

  5. Parts 1 and 2: Progression-free Survival (PFS)

    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).

    Measured: Up to approximately 2 years

  6. Parts 1 and 2: Overall Survival (OS)

    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.

    Measured: Up to approximately 2 years

  7. Part 2: Number of Participants Who Experience a TEAE

    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.

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

  8. Part 2: Number of Participants Who Experience a Treatment-related AE

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

  9. Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab

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

  10. Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab

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

  11. Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab

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

Timeline

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

  1. First posted13 Apr 2022
  2. Study start23 Sep 2022
  3. Primary completion28 Jan 2026
  4. Study completion28 Jan 2026

Why it stopped: Sponsor Decision

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325866
Sponsor's protocol ID
20210104
Other IDs
2023-505455-44, 2023
Acronym
FORTITUDE-301
Status last verified
Jun 2026
First submitted
6 Apr 2022
Last updated
22 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bemarituzumab in people with Solid Tumors, run by Amgen at 115 sites in 26 countries.

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 15 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, France, Argentina, Brazil, Australia and 21 more countries. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

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?

Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) (time frame: Day 1 to Day 28). The study lists 4 primary outcomes in all. 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 NCT05325866.

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 22 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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