A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102)

Amgen Inc.0 个研究点目标入组 528 人开始时间: 2022年4月22日最近更新: 2024年2月26日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 528

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Inclusion Criteria Part 1:
•- Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
•- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
•- Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
•- Participant must be a candidate to receive mFOLFOX6 and nivolumab
•- Adequate organ function as follows:
•Absolute neutrophil count = 1.5 x 10^9/L
•Platelet count = 100 x 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 aminotransaminase (AST) and Alanine
•aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x
•ULN if liver involvement). Total bilirubin <1.5 x ULN (or < 2 x ULN if
•liver involvement; or Gilbert's disease)
•Part 1 only: Calculated or measured creatinine clearance (CrCl) of = 50 mL/minute calculated using the formula of Cockcroft and Gault
•Part 2 only: Calculated or measured creatinine clearance (CrCl) of = 30 mL/minute calculated using the formula of Cockcroft and Gault
•International Normalized Ratio (INR) or prothrombin time (PT) < 1.5 ×
•ULN except for participants receiving anticoagulation, who must be on a
•stable dose of anticoagulant therapy for 6 weeks prior to enrollment.
•Subject has no contraindications to nivolumab and either mFOLFOX6 or CAPOX chemotherapy as per local prescribing information. Subjects in Part 1 must have no contraindications to mFOLFOX6. Subjects in Part 2 with contraindications to mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no contraindications for this regimen exist. Subjects in Part 2 with contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen, if no contraindications for this regimen exist.
•Additional Inclusion Criteria Part 2:
•- No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of chemotherapy with or without nivolumab. Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment.
•- Confirmed FGFR2b = 10% 2+/3+ TC by centrally performed immunohistochemistry (IHC) testing based on tumor sample either archival (obtained within 6 months/180 days prior to signing prescreening informed consent) or a fresh biopsy.
•- For subjects receiving CAPOX only, the ability to take oral medication.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 406
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 122

排除标准

•- Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
•- Known positive human epidermal growth factor receptor 2 (HER2) status
•- Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
•- Peripheral sensory neuropathy grade 2 or higher
•- Clinically significant cardiac disease
•- Other malignancy within the last 2 years (exceptions for definitively treated disease)
•- Chronic or systemic ophthalmologic disorders
•- Major surgery or other investigational study within 28 days prior to randomization
•- Palliative radiotherapy within 14 days prior to randomization
•- Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
•- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
•- For subjects receiving CAPOX only, GI tract disease causing the inability to take oral medication, malabsorption syndrome, or requirement for IV alimentation, or uncontrolled inflammatory GI disease (eg, Crohn's disease, ulcerative colitis)
•Please refer to protocol for remaining exclusion criteria

研究者

发起方

Amgen Inc.

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