A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression MedDRA version: 21.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10055476 Term: Esophageal squamous cell carcinoma System Organ Class: 10029104 - N
Conditions
Interventions
Product Name: Bemarituzumab
Product Code: AMG 552
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BEMARITUZUMAB
CAS Number: 1952272-74-0
Current Sponsor code: AMG 552
Concentration uni
Sponsors
Amgen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 225
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1b: •To observe the safety and tolerability of bemarituzumab Phase 2: •To evaluate preliminary antitumor activity;Secondary Objective: 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;Primary 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);Timepoint(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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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);Timepoint(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) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactIHQ medical Info-Clinical Trials
AMGEN S.A.
Outcome results
None listed