Clinical trial NCT05325866: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-04-13
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
timeFrame: Day 1 to Day 28
measure: Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 to 28 days after last dose (a maximum of 2 years)
measure: Part 1: Number of Participants Who Experience a Treatment-related Adverse Event
timeFrame: Day 1 to 28 days after last dose (a maximum of 2 years)
measure: Part 2: Objective Response (OR) Rate
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Part 1: OR Rate
timeFrame: Up to approximately 2 years
measure: Parts 1 and 2: Disease Control (DC) Rate
timeFrame: Up to approximately 2 years
measure: Parts 1 and 2: Duration of Response (DOR)
timeFrame: Up to approximately 2 years
measure: Parts 1 and 2: Time to Response
timeFrame: Up to approximately 2 years
measure: Parts 1 and 2: Progression-free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Parts 1 and 2: Overall Survival (OS)
timeFrame: Up to approximately 2 years
measure: Part 2: Number of Participants Who Experience a TEAE
timeFrame: Day 1 to 28 days after last dose (a maximum of 2 years)
measure: Part 2: Number of Participants Who Experience a Treatment-related AE
timeFrame: Day 1 to 28 days after last dose (a maximum of 2 years)
measure: Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
timeFrame: Day 1 to 28 days after last dose (a maximum of 2 years)
measure: Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
timeFrame: Day 1 to 28 days after last dose (a maximum of 2 years)
measure: Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
timeFrame: Day 1 to 28 days after last dose (a maximum of 2 years)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Indianapolis
country: United States
facility: Community Health Network MD Anderson Cancer Center - North
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Nashville
country: United States
facility: United States Oncology Regulatory Affairs Corporate Office
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Dallas Fort Worth
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Research Investigational Products Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology Northeast Texas
state: Texas
city: Capital Federal
country: Argentina
facility: Instituto Alexander Fleming
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Aleman
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Cenit Para La Investigacion
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Sociedad de Beneficencia Hospital Italiano
state: Córdoba
city: Cipolletti
country: Argentina
facility: Fundacion Medica de Rio Negro y Neuquen
state: Río Negro
city: Buenos Aires
country: Argentina
facility: Centro Oncologico Korben
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Toowoomba
country: Australia
facility: Toowoomba Hospital
state: Queensland
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi - Site des Viviers
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas da Ufmg
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Centro de Oncologia Mackenzie
state: Paraná
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer Arnaldo Vieira de Carvalho
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Beneficencia Portuguesa de Sao Paulo - Bp
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Oncologia Rede D Or
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Kobenhavn O
country: Denmark
facility: Rigshospitalet
city: Helsinki
country: Finland
facility: Docrates Syopasairaala
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Angers Cedex 02
country: France
facility: Institut de Cancerologie de l Ouest Rene Gauducheau
city: Besancon
country: France
facility: Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
city: Lille Cedex
country: France
facility: Centre Oscar Lambret
city: Marseille Cedex 09
country: France
facility: Institut Paoli Calmettes
city: Montpellier Cedex 5
country: France
facility: Institut regional du Cancer Montpellier
city: Pierre-Benite
country: France
facility: Hopital Lyon sud
city: Toulouse cedex 9
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
city: Villejuif
country: France
facility: Gustave Roussy
city: Athens
country: Greece
facility: Sotiria General Hospital
city: Athens
country: Greece
facility: Alexandra Hospital
city: Athens
country: Greece
facility: Metropolitan General
city: Heraklion - Crete
country: Greece
facility: University Hospital of Heraklion
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein-Kerem Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Candiolo TO
country: Italy
facility: Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
city: Mirano
country: Italy
facility: Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano
city: Napoli
country: Italy
facility: Ospedale del Mare
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Umberto I
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: La Paz
country: Mexico
facility: Investigacion Onco Farmacéutica S de RL de CV
state: Baja California Sur
city: Saltillo
country: Mexico
facility: Centro de Infusion e Investigacion Oncologia de Saltillo
state: Coahuila
city: Ciudad de Mexico
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Health Pharma Professional Research SA de CV
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Christus Muguerza Clinica Vidriera
state: Nuevo León
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum
city: Krakow
country: Poland
facility: Pratia Mcm Krakow
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Pila
country: Poland
facility: Ars Medical Spzoo
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
city: Lisboa
country: Portugal
facility: Hospital da Luz, SA
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf Nectarie SRL
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Timisoara
country: Romania
facility: SC Oncomed SRL
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: Galicia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Geneve 14
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: