A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
- Conditions
- Gastroesophageal Junction CancerGastric Cancer
- Interventions
- Registration Number
- NCT05322577
- Lead Sponsor
- Amgen
- Brief Summary
The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy.
- Ability to provide tumor sample, either archival (obtained within 6 months to joining study) or fresh biopsy.
- For certain arms for Part 1, FGFR2b overexpression positive defined as any FGFR2b 2+/3+ TC determined by centrally performed immunohistochemistry (IHC), based on tumor sample provided.
- For Part 2, FGFR2b overexpression positive defined as FGFR2b ≥10% 2+/3+ TC determined by centrally performed IHC testing, based on tumor sample provided.
- Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
- Measurable or non-measurable disease as long as evaluable by Response Evaluation Criteria Solid Tumors (RECIST) version 1.1
- Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.
- Adequate organ function.
- For Part 2, measurable disease according to RECIST v1.1.
- Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose).
- 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 of first study treatment dose.
- Palliative radiotherapy within 14 days of first study treatment dose.
- Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
- History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab SOX - Part 1 Cohort A: Bemarituzumab with CAPOX CAPOX - Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab CAPOX - Part 2: Bemarituzumab with SOX and Nivolumab. SOX - Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab Nivolumab - Part 2: Bemarituzumab with SOX and Nivolumab. Bemarituzumab - Part 2: Bemarituzumab with SOX and Nivolumab. Nivolumab - Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab Nivolumab - Part 1 Cohort A: Bemarituzumab with CAPOX Bemarituzumab - Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab Bemarituzumab - Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab Bemarituzumab -
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) Day 1 to end of treatment (up to approximately 1 year) Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Day 1 up to Day 21 Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to 30 Months
- Secondary Outcome Measures
Name Time Method Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab Day 1 to end of treatment (up to approximately 1 year) Part 1: Duration of Response (DoR) per RECIST v1.1 Up to 2 years Part 2: PFS per RECIST v1.1 Up to 30 months Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab Day 1 to end of treatment (up to approximately 1 year)) Part 1: Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab Day 1 to end of treatment (up to approximately 1 year) Part 2: Number of Participants Who Experience TEAEs Up to 30 months Part 2: DoR per RECIST v1.1 Up to 30 months Part 2: Time to Response (TTR) per RECIST v1.1 Up to 30 months Part 1: OR per RECIST v1.1 Up to 2 years Part 1: Progression-free Survival (PFS) per RECIST v1.1 Up to 2 years Part 1: Overall Survival (OS) Up to 2 years Part 2: Disease Control (DC) per RECIST v1.1 Up to 30 months Part 1: Disease Control Rate (DCR) Up to 2 years Part 2: OS Up to 30 months
Trial Locations
- Locations (40)
Northport Veterans Affairs Medical Center
🇺🇸Northport, New York, United States
Fujita Health University Hospital
🇯🇵Toyoake-shi, Aichi, Japan
Hirosaki University Hospital
🇯🇵Hirosaki-shi, Aomori, Japan
Chiba University Hospital
🇯🇵Chiba-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-shi, Ehime, Japan
Fukui Prefectural Hospital
🇯🇵Fukui-Shi, Fukui, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima-shi, Fukushima, Japan
Gifu University Hospital
🇯🇵Gifu-shi, Gifu, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki-shi, Gifu, Japan
Gunma University Hospital
🇯🇵Maebashi-shi, Gunma, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota-shi, Gunma, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Hiroshima University Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Ibaraki Prefectural Central Hospital
🇯🇵Kasama-shi, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
Kagawa University Hospital
🇯🇵Kita-gun, Kagawa, Japan
St Marianna University Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Kochi Health Sciences Center
🇯🇵Kochi-shi, Kochi, Japan
Kyoto University Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Okayama University Hospital
🇯🇵Okayama-shi, Okayama, Japan
Osaka General Medical Center
🇯🇵Osaka-shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki-shi, Osaka, Japan
Shizuoka General Hospital
🇯🇵Shizuoka-shi, Shizuoka, Japan
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
Dokkyo Medical University Hospital
🇯🇵Shimotsuga-gun, Tochigi, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
IMSUT Hospital, The Institute of Medical Science The University of Tokyo
🇯🇵Minato-ku, Tokyo, Japan
Toyama University Hospital
🇯🇵Toyama-shi, Toyama, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National University Hospital
🇸🇬Singapore, Singapore
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan