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

Solid Tumors Clinical Trial

— FORTITUDE-301  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325866
• Other study ID #: 20210104
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 23, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 303
• Est. completion date: June 30, 2027
• Est. primary completion date: September 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• Bemarituzumab
Intravenous (IV) infusion.

Locations

Country	Name	City	State
Argentina	Centro Oncologico Korben	Buenos Aires
Argentina	Instituto Alexander Fleming	Capital Federal	Buenos Aires
Argentina	Fundacion Medica de Rio Negro y Neuquen	Cipolletti	Río Negro
Argentina	Fundacion Cenit Para La Investigacion	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Hospital Aleman	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Sociedad de Beneficencia Hospital Italiano	Cordoba	Córdoba
Argentina	Hospital Italiano de La Plata	La Plata	Buenos Aires
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Cabrini Hospital	Malvern	Victoria
Australia	St John of God Murdoch Hospital	Murdoch	Western Australia
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Toowoomba Hospital	Toowoomba	Queensland
Australia	Wollongong Hospital	Wollongong	New South Wales
Austria	Medizinische Universitaet Graz	Graz
Austria	Landeskrankenhaus Salzburg	Salzburg
Belgium	Universite Catholique de Louvain Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Grand Hopital de Charleroi	Charleroi
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven
Brazil	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	Oncoclinicas Rio de Janeiro S A	Rio de Janeiro
Brazil	Beneficencia Portuguesa de Sao Paulo	Sao Paulo	São Paulo
Brazil	Instituto do Cancer Arnaldo Vieira de Carvalho	Sao Paulo	São Paulo
Brazil	Oncologia Rede D Or	Sao Paulo	São Paulo
Bulgaria	Complex Oncology Center Plovdiv EOOD	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment Central Onco Hospital OOD	Plovdiv
Bulgaria	Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia	Sofia
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Denmark	Rigshospitalet	Kobenhavn O
Finland	Docrates Syopasairaala	Helsinki
Finland	Tampere University Hospital	Tampere
France	Institut de Cancerologie de l Ouest Rene Gauducheau	Angers Cedex 02
France	Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz	Besancon cedex
France	Centre Oscar Lambret	Lille Cedex
France	Institut Paoli Calmettes	Marseille Cedex 09
France	Institut regional du Cancer Montpellier	Montpellier Cedex 5
France	Centre Hospitalier Lyon Sud	Pierre-Benite
France	Institut Claudius Regaud	Toulouse cedex 9
France	Institut Gustave Roussy	Villejuif
Greece	Alexandra Hospital	Athens
Greece	Metropolitan General	Athens
Greece	Sotiria General Hospital	Athens
Greece	University Hospital of Heraklion	Heraklion - Crete
Greece	European Interbalkan Medical Center	Thessaloniki
Hungary	Orszagos Onkologiai Intezet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz	Nyiregyhaza
Hungary	Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok
Israel	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
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia	Foggia
Italy	Azienda Unità Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano	Mirano
Italy	Ospedale del Mare	Napoli
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	The Cancer Institute Hospital of Japanese Foundation for Cancer Research	Koto-ku	Tokyo
Japan	Aichi Cancer Center	Nagoya-shi	Aichi
Japan	Kindai University Hospital	Osakasayama-shi	Osaka
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos	Ciudad de Mexico	Distrito Federal
Mexico	Investigación Onco Farmacéutica S de RL de CV	La Paz	Baja California Sur
Mexico	Health Pharma Professional Research SA de CV	Mexico City	Distrito Federal
Mexico	Christus Muguerza Clinica Vidriera	Monterrey	Nuevo León
Mexico	Centro de Infusion e Investigacion Oncologia de Saltillo	Saltillo	Coahuila
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Radboud Universitair Medisch Centrum	Nijmegen
Poland	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
Portugal	Centro Hospitalar de Lisboa Ocidental, EPE, Hospital Sao Francisco Xavier	Lisboa
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria	Lisboa
Portugal	Hospital da Luz, SA	Lisboa
Romania	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
Spain	Hospital Clinico Universitario Virgen de la Victoria	Malaga	Andalucía
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela	Galicia
Switzerland	Kantonsspital Graubuenden	Chur
Switzerland	Hopitaux Universitaires de Geneve	Geneve
United Kingdom	Christie Hospital	Manchester
United Kingdom	Weston Park Hospital	Sheffield
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Texas Oncology - Dallas Fort Worth	Dallas	Texas
United States	US Oncology Regulatory Affairs Corporate Office	Denver	Colorado
United States	US Oncology Research Investigational Products Center	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Community Health Network MD Anderson Cancer Center - North	Indianapolis	Indiana
United States	University of California Irvine	Orange	California
United States	Texas Oncology Northeast Texas	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  France,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)		Day 1 to Day 28
Primary	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)
Primary	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)
Primary	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	Part 1: OR Rate	OR = CR + PR, measured by CT or MRI as determined by investigator per RECIST v1.1.	Up to approximately 2 years
Secondary	Parts 1 and 2: Disease Control (DC) Rate	DC = CR, PR, or stable disease (SD).	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	Parts 1 and 2: Time to Response		Up to approximately 2 years
Secondary	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).	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	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.	Day 1 to 28 days after last dose (a maximum of 2 years)
Secondary	Part 2: Number of Participants Who Experience a Treatment-related AE		Day 1 to 28 days after last dose (a maximum of 2 years)
Secondary	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)
Secondary	Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab		Day 1 to 28 days after last dose (a maximum of 2 years)
Secondary	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)

External Links

•   AmgenTrials clinical trials website