Clinical Trials List
Protocol Number20210096
NCT Number(ClinicalTrials.gov Identfier)NCT05052801
Active
2021-12-01 - 2026-11-30
Phase III
Recruiting5
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 黃敬文 Division of Colorectal Surgery
- 蔡祥麟 Division of Colorectal Surgery
- Yen-Cheng Chen Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李易濰 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 黃詩喻 Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- 郭明濬 Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chi Chou Division of Hematology & Oncology
- Hung-Chih Hsu Division of Hematology & Oncology
- 陳宏吉 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王秀慈 Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Jui Yen
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Gastric Cancer
Objectives
This is a randomized, multicenter, double-blind, placebo-controlled phase 3 trial evaluating the efficacy, safety, and tolerability of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 in patients with advanced gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma exhibiting FGFR2b at ≥10% tumor cells with moderate (2+) to strong (3+) membrane staining (FGFR2b ≥ 10% 2+/3+ TC), and who have unresectable or previously untreated metastatic sites. FGFR2b status (FGFR2b ≥ 10% 2+/3+ TC) will be assessed by a central laboratory at pre-screening using immunohistochemical staining (IHC) on sealed tissue sections (obtained within 6 months/180 days prior to signing the pre-screening consent form) or new tissue sections.
Primary Objective:
Compare the efficacy of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 in patients with FGFR2b ≥ 10% 2+/3+ tumor cell staining (FGFR2b ≥ 10% 2+/3+ TC), assessed by overall survival (OS).
Key Secondary Objectives:
Compare the efficacy of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 in patients with FGFR2b ≥ 10% 2+/3+ TC, assessed by progression-free survival (PFS).
Compare the efficacy of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 in patients with FGFR2b ≥ 10% 2+/3+ TC, assessed by objective response (OR).
Evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6.
Other secondary objectives:
Compare the efficacy of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 in all randomized subjects, assessing:
- Overall survival (OS)
- Progression-free survival (PFS)
- Overall response (OR)
Compare the efficacy between treatment groups in subjects with FGFR2b ≥10% 2+/3+ TC, assessing:
- Duration of response (DOR)
- Disease control
Assess patient self-reported outcomes and quality of life (QoL) in subjects with FGFR2b ≥10% 2+/3+ TC
Investigate the pharmacokinetics (PK) of bemarituzumab combined with mFOLFOX6
Investigate the immunogenicity of bemarituzumab
Test Drug
靜脈點滴注射劑
Active Ingredient
Bemarituzumab (AMG 552, FPA144)
Dosage Form
242
Dosage
20 mg/ml, 20 mL/vial
Endpoints
Overall survival is defined as the time from randomization until death from any cause. Surviving subjects will be limited to those whose last known date of survival is known.
Inclution Criteria
Inclusion Criteria:
Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
Participant has no contraindications to mFOLFOX6 chemotherapy
Adequate organ and bone marrow function:
absolute neutrophil count greater than or equal to 1.5 times 10^9/L
platelet count greater than or equal to 100 times 10^9/L
hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
Participant has no contraindications to mFOLFOX6 chemotherapy
Adequate organ and bone marrow function:
absolute neutrophil count greater than or equal to 1.5 times 10^9/L
platelet count greater than or equal to 100 times 10^9/L
hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Exclusion Criteria
Exclusion Criteria:
Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
Known human epidermal growth factor receptor 2 (HER2) positive
Untreated or symptomatic central nervous system (CNS) disease or brain metastases
Peripheral sensory neuropathy greater than or equal to Grade 2
Clinically significant cardiac disease
Other malignancy within the last 2 years (exceptions for definitively treated disease)
Chronic or systemic ophthalmological disorders
Major surgery or other investigational study within 28 days prior to first dose of study treatment
Palliative radiotherapy within 14 days prior to the first dose of study treatment
Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
Known human epidermal growth factor receptor 2 (HER2) positive
Untreated or symptomatic central nervous system (CNS) disease or brain metastases
Peripheral sensory neuropathy greater than or equal to Grade 2
Clinically significant cardiac disease
Other malignancy within the last 2 years (exceptions for definitively treated disease)
Chronic or systemic ophthalmological disorders
Major surgery or other investigational study within 28 days prior to first dose of study treatment
Palliative radiotherapy within 14 days prior to the first dose of study treatment
Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
The Estimated Number of Participants
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Taiwan
19 participants
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Global
516 participants
