A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Phase 1
Active, not recruiting
- 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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 2: OS Up to 30 months Part 1: Disease Control Rate (DCR) Up to 2 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie bemarituzumab's efficacy in FGFR2b-positive gastric cancer?
How does bemarituzumab combination therapy compare to standard-of-care in advanced gastroesophageal junction cancer?
Which biomarkers are associated with response to bemarituzumab plus SOX or nivolumab in gastric cancer?
What are the potential adverse events of bemarituzumab combined with oxaliplatin-based regimens?
How do FGFR inhibitors like bemarituzumab synergize with immune checkpoint inhibitors in GI cancers?
Trial Locations
- Locations (42)
Northport Veterans Affairs Medical Center
🇺🇸Northport, New York, United States
Fujita Health University Hospital
🇯🇵Toyoake-shi, Aichi-ken, Japan
Hirosaki University Hospital
🇯🇵Hirosaki-shi, Aomori, Japan
Chiba University Hospital
🇯🇵Chiba, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
Fukui Prefectural Hospital
🇯🇵Fukui-shi, Fukui, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Fukushima, Japan
Gifu University Hospital
🇯🇵Gifu, Gifu, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki-shi, Gifu, Japan
Scroll for more (32 remaining)Northport Veterans Affairs Medical Center🇺🇸Northport, New York, United States