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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05325866




Registration number
NCT05325866
Ethics application status
Date submitted
6/04/2022
Date registered
13/04/2022

Titles & IDs
Public title
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Scientific 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)
Secondary ID [1] 0 0
20210104
Universal Trial Number (UTN)
Trial acronym
FORTITUDE-301
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bemarituzumab

Experimental: Part 1: Monotherapy Dose Exploration - 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.

Experimental: Part 2: Monotherapy Dose Expansion - 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.


Treatment: Drugs: Bemarituzumab
Intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
Day 1 to Day 28
Primary outcome [2] 0 0
Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timepoint [2] 0 0
Day 1 to 28 days after last dose (a maximum of 2 years)
Primary outcome [3] 0 0
Part 1: Number of Participants Who Experience a Treatment-related Adverse Event
Timepoint [3] 0 0
Day 1 to 28 days after last dose (a maximum of 2 years)
Primary outcome [4] 0 0
Part 2: Objective Response (OR) Rate
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Part 1: OR Rate
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Parts 1 and 2: Disease Control (DC) Rate
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Parts 1 and 2: Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Parts 1 and 2: Time to Response
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Parts 1 and 2: Progression-free Survival (PFS)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Parts 1 and 2: Overall Survival (OS)
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Part 2: Number of Participants Who Experience a TEAE
Timepoint [7] 0 0
Day 1 to 28 days after last dose (a maximum of 2 years)
Secondary outcome [8] 0 0
Part 2: Number of Participants Who Experience a Treatment-related AE
Timepoint [8] 0 0
Day 1 to 28 days after last dose (a maximum of 2 years)
Secondary outcome [9] 0 0
Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Timepoint [9] 0 0
Day 1 to 28 days after last dose (a maximum of 2 years)
Secondary outcome [10] 0 0
Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
Timepoint [10] 0 0
Day 1 to 28 days after last dose (a maximum of 2 years)
Secondary outcome [11] 0 0
Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Timepoint [11] 0 0
Day 1 to 28 days after last dose (a maximum of 2 years)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/07/2027
Actual
Sample size
Target
303
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [4] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [5] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [6] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4350 - Toowoomba
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Córdoba
Country [8] 0 0
Argentina
State/province [8] 0 0
Río Negro
Country [9] 0 0
Austria
State/province [9] 0 0
Graz
Country [10] 0 0
Austria
State/province [10] 0 0
Salzburg
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Charleroi
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Brazil
State/province [16] 0 0
Minas Gerais
Country [17] 0 0
Brazil
State/province [17] 0 0
Paraná
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Sul
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio de Janeiro
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Plovdiv
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno
Country [26] 0 0
Czechia
State/province [26] 0 0
Hradec Kralove
Country [27] 0 0
Czechia
State/province [27] 0 0
Olomouc
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 10
Country [29] 0 0
Denmark
State/province [29] 0 0
Kobenhavn O
Country [30] 0 0
Finland
State/province [30] 0 0
Helsinki
Country [31] 0 0
Finland
State/province [31] 0 0
Tampere
Country [32] 0 0
France
State/province [32] 0 0
Angers Cedex 02
Country [33] 0 0
France
State/province [33] 0 0
Besancon cedex
Country [34] 0 0
France
State/province [34] 0 0
Lille Cedex
Country [35] 0 0
France
State/province [35] 0 0
Marseille Cedex 09
Country [36] 0 0
France
State/province [36] 0 0
Montpellier Cedex 5
Country [37] 0 0
France
State/province [37] 0 0
Pierre-Benite
Country [38] 0 0
France
State/province [38] 0 0
Toulouse cedex 9
Country [39] 0 0
France
State/province [39] 0 0
Villejuif
Country [40] 0 0
Greece
State/province [40] 0 0
Athens
Country [41] 0 0
Greece
State/province [41] 0 0
Heraklion - Crete
Country [42] 0 0
Greece
State/province [42] 0 0
Thessaloniki
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Nyiregyhaza
Country [45] 0 0
Hungary
State/province [45] 0 0
Szolnok
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa
Country [47] 0 0
Israel
State/province [47] 0 0
Jerusalem
Country [48] 0 0
Israel
State/province [48] 0 0
Petah Tikva
Country [49] 0 0
Israel
State/province [49] 0 0
Ramat Gan
Country [50] 0 0
Israel
State/province [50] 0 0
Tel Aviv
Country [51] 0 0
Italy
State/province [51] 0 0
Candiolo TO
Country [52] 0 0
Italy
State/province [52] 0 0
Foggia
Country [53] 0 0
Italy
State/province [53] 0 0
Mirano
Country [54] 0 0
Italy
State/province [54] 0 0
Napoli
Country [55] 0 0
Italy
State/province [55] 0 0
Pisa
Country [56] 0 0
Japan
State/province [56] 0 0
Aichi
Country [57] 0 0
Japan
State/province [57] 0 0
Chiba
Country [58] 0 0
Japan
State/province [58] 0 0
Osaka
Country [59] 0 0
Japan
State/province [59] 0 0
Tokyo
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul
Country [61] 0 0
Mexico
State/province [61] 0 0
Baja California Sur
Country [62] 0 0
Mexico
State/province [62] 0 0
Coahuila
Country [63] 0 0
Mexico
State/province [63] 0 0
Distrito Federal
Country [64] 0 0
Mexico
State/province [64] 0 0
Nuevo León
Country [65] 0 0
Netherlands
State/province [65] 0 0
Groningen
Country [66] 0 0
Netherlands
State/province [66] 0 0
Nijmegen
Country [67] 0 0
Poland
State/province [67] 0 0
Krakow
Country [68] 0 0
Poland
State/province [68] 0 0
Lodz
Country [69] 0 0
Poland
State/province [69] 0 0
Pila
Country [70] 0 0
Poland
State/province [70] 0 0
Siedlce
Country [71] 0 0
Poland
State/province [71] 0 0
Skorzewo
Country [72] 0 0
Portugal
State/province [72] 0 0
Lisboa
Country [73] 0 0
Romania
State/province [73] 0 0
Cluj Napoca
Country [74] 0 0
Romania
State/province [74] 0 0
Craiova
Country [75] 0 0
Romania
State/province [75] 0 0
Iasi
Country [76] 0 0
Romania
State/province [76] 0 0
Timisoara
Country [77] 0 0
Spain
State/province [77] 0 0
Andalucía
Country [78] 0 0
Spain
State/province [78] 0 0
Cataluña
Country [79] 0 0
Spain
State/province [79] 0 0
Galicia
Country [80] 0 0
Spain
State/province [80] 0 0
Madrid
Country [81] 0 0
Switzerland
State/province [81] 0 0
Chur
Country [82] 0 0
Switzerland
State/province [82] 0 0
Geneve
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Manchester
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05325866