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    Summary
    EudraCT Number:2021-006386-38
    Sponsor's Protocol Code Number:20210104
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-03-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2021-006386-38
    A.3Full title of the trial
    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)
    doplnit podle synopse protokolu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating Bemarituzumab in Solid Tumors with Fibroblast growth factor receptor 2b (FGFR2b) Overexpression
    A.4.1Sponsor's protocol code number20210104
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen s.r.o.
    B.5.2Functional name of contact pointCZ Medical Information
    B.5.3 Address:
    B.5.3.1Street AddressKlimentská 1216/46
    B.5.3.2Town/ cityPraha 1
    B.5.3.3Post code110 02
    B.5.3.4CountryCzechia
    B.5.4Telephone number+420 221 773 500
    B.5.6E-maileu-cz-medinfo@amgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBemarituzumab
    D.3.2Product code AMG 552
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEMARITUZUMAB
    D.3.9.1CAS number 1952272-74-0
    D.3.9.2Current sponsor codeAMG 552
    D.3.9.4EV Substance CodeSUB195744
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression
    E.1.1.1Medical condition in easily understood language
    A Study Evaluating Bemarituzumab in Solid Tumors with FGFR2b Overexpression
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10055476
    E.1.2Term Esophageal squamous cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073364
    E.1.2Term Ductal adenocarcinoma of pancreas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10073077
    E.1.2Term Intrahepatic cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10052360
    E.1.2Term Colorectal adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10033131
    E.1.2Term Ovarian carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10014720
    E.1.2Term Endometrial adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008239
    E.1.2Term Cervical carcinoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b:
    •To observe the safety and tolerability of bemarituzumab
    Phase 2:
    •To evaluate preliminary antitumor activity
    E.2.2Secondary objectives of the trial
    Phase 1b:
    •To evaluate other measures of preliminary antitumor activity
    •Characterize the PK of bemarituzumab monotherapy
    Phase 2:
    •To evaluate other measures of preliminary antitumor activity
    •To evaluate the safety and tolerability of bemarituzumab
    •Characterize the PK of bemarituzumab monotherapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults with 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:
    - head and neck squamous cell carcinoma: more than or equal to 1 line of therapy
    -esophageal squamous cell carcinoma: more than or equal to 1 line of therapy
    -triple-negative breast cancer: more than or equal to 2 lines of therapy
    -pancreatic ductal adenocarcinoma: more than or equal to 1 line of therapy
    -Intrahepatic cholangiocarcinoma more than or equal to 1 line of therapy
    -colorectal adenocarcinoma: more than or equal to 2 lines of therapy
    -platinum-resistant ovarian epithelial carcinoma, defined as progression during or within 6 months of a platinum containing regimen: more than or equal to 1 line of therapy
    -endometrial adenocarcinoma: more than or equal to 1 line of therapy
    -cervical carcinoma: more than or equal to 1 line of therapy
    -other solid tumors: more than or equal to 1 line of therapy
    •Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing
    •Measurable disease per RECIST v1.1
    •Adequate hematologic and organ function, defined as follows:
    -Absolute neutrophil count more than or equal to 1.5 x 109/L
    -Platelet count more than or equal to 100 x 109/L
    -Hemoglobin more than or equal to 9 g/dL
    -AST and ALT less than 3 x upper limit of Normal [ULN] (or < 5 x ULN in case of liver involvement). Total bilirubin less than 1.5 x ULN (or less than 2 x ULN in case of liver involvement OR Gilbert’s disease)

    For more details please see section 5.1 Inclusion Criteria within the Protocol
    E.4Principal exclusion criteria
    •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 carcinoma, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma
    •History of other malignancy within the past 2 years (see exceptions within the Protocol)
    •Impaired cardiac function or clinically significant cardiac disease
    •Active infection requiring systemic treatment or any uncontrolled infection within 14 days prior to first dose of study treatment
    •Known human immunodeficiency virus (HIV) infection
    •History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroids
    •Prior treatment with any investigational selective inhibitor of the FGF-FGFR pathway (unless approved standard of care for tumor indication)
    •Any anticancer therapy or immunotherapy within 4 weeks prior to enrollment (see additional details within the Protocol)
    •Major surgical procedure within 28 days prior to first dose of study treatment.
    •Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.

    For more details please see section 5.2 Exclusion Criteria within the Protocol
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    •Dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and clinically significant changes in vital signs, visual acuity, and clinical laboratory tests
    Phase 2:
    •Objective Response (OR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints to be assessed throughout the course of the study. (See Table 1-1 in section 1.3 Schedule of Activities in Protocol)
    E.5.2Secondary end point(s)
    Phase 1 and Phase 2:
    Objective response (OR)
    •Disease control (DC) (CR, PR, or stable disease [SD])
    •Duration of response (DOR)
    •Time to response (TTR)
    •Progression-free survival (PFS)
    •Overall survival (OS)
    •PK parameters for bemarituzumab including, but not limited to, AUC, Cmax, and Ctrough
    •PK parameters for bemarituzumab including, but not limited to, area under the concentration time curve (AUC), maximum observed concentration (Cmax), and the observed concentration at the end of a dose interval (Ctrough)
    E.5.2.1Timepoint(s) of evaluation of this end point
    OR, DC, DOR, TTR, PFS:
    •Radiographic assessment to be performed every 8 weeks (± 7 days) until week 56 and then every 12 weeks (± 14 days) until radiographic progression or initiation of subsequent anticancer therapy.
    OS:
    •To be assessed after subject enrollment and throughout the course of the study. After safety follow-up subjects will undergo long term follow-up for survival approximately every 3 months (± 1 month) for up to 2 years from the first dose of bemarituzumab. (See Table 1-1 in section 1.3 Schedule of Activities in Protocol)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Assess tolerability, characterize immunogenicity and biomarkers
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Turkey
    United States
    Austria
    Belgium
    Czechia
    Denmark
    Finland
    France
    Greece
    Hungary
    Italy
    Poland
    Portugal
    United Kingdom
    Netherlands
    Romania
    Spain
    Switzerland
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), including any additional parts in the study (eg, long-term follow-up, antibody testing), as applicable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 375
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-02
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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