Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05325866




Registration number
NCT05325866
Ethics application status
Date submitted
6/04/2022
Date registered
13/04/2022
Date last updated
30/05/2024

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/Phase 2
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
Foggia
Country [52] 0 0
Italy
State/province [52] 0 0
Mirano
Country [53] 0 0
Italy
State/province [53] 0 0
Napoli
Country [54] 0 0
Italy
State/province [54] 0 0
Pisa
Country [55] 0 0
Japan
State/province [55] 0 0
Aichi
Country [56] 0 0
Japan
State/province [56] 0 0
Chiba
Country [57] 0 0
Japan
State/province [57] 0 0
Osaka
Country [58] 0 0
Japan
State/province [58] 0 0
Tokyo
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Mexico
State/province [60] 0 0
Baja California Sur
Country [61] 0 0
Mexico
State/province [61] 0 0
Coahuila
Country [62] 0 0
Mexico
State/province [62] 0 0
Distrito Federal
Country [63] 0 0
Mexico
State/province [63] 0 0
Nuevo León
Country [64] 0 0
Netherlands
State/province [64] 0 0
Groningen
Country [65] 0 0
Netherlands
State/province [65] 0 0
Nijmegen
Country [66] 0 0
Poland
State/province [66] 0 0
Krakow
Country [67] 0 0
Poland
State/province [67] 0 0
Lodz
Country [68] 0 0
Poland
State/province [68] 0 0
Pila
Country [69] 0 0
Poland
State/province [69] 0 0
Siedlce
Country [70] 0 0
Poland
State/province [70] 0 0
Skorzewo
Country [71] 0 0
Portugal
State/province [71] 0 0
Lisboa
Country [72] 0 0
Romania
State/province [72] 0 0
Cluj Napoca
Country [73] 0 0
Romania
State/province [73] 0 0
Craiova
Country [74] 0 0
Romania
State/province [74] 0 0
Iasi
Country [75] 0 0
Romania
State/province [75] 0 0
Timisoara
Country [76] 0 0
Spain
State/province [76] 0 0
Andalucía
Country [77] 0 0
Spain
State/province [77] 0 0
Galicia
Country [78] 0 0
Switzerland
State/province [78] 0 0
Chur
Country [79] 0 0
Switzerland
State/province [79] 0 0
Geneve
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of this study are to observe the safety and tolerability of
bemarituzumab and to evaluate preliminary antitumor activity.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05325866
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
medinfo@amgen.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05325866