A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
- Conditions
- Gastric CancerGastroesophageal Junction Cancer
- Registration Number
- NCT05322577
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria:<br><br> - Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal<br> junction cancer not amendable to curative therapy.<br><br> - Ability to provide tumor sample, either archival (obtained within 6 months to<br> joining study) or fresh biopsy.<br><br> - For certain arms for Part 1, FGFR2b overexpression positive defined as any FGFR2b<br> 2+/3+ TC determined by centrally performed immunohistochemistry (IHC), based on<br> tumor sample provided.<br><br> - For Part 2, FGFR2b overexpression positive defined as FGFR2b =10% 2+/3+ TC<br> determined by centrally performed IHC testing, based on tumor sample provided.<br><br> - Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.<br><br> - Measurable or non-measurable disease as long as evaluable by Response Evaluation<br> Criteria Solid Tumors (RECIST) version 1.1<br><br> - Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.<br><br> - Adequate organ function.<br><br> - For Part 2, measurable disease according to RECIST v1.1.<br><br>Exclusion Criteria:<br><br> - Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or<br> neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st<br> dose).<br><br> - Prior treatment with any selective inhibitor of fibroblast growth factor -<br> fibroblast growth factor receptor (FGF-FGFR) pathway.<br><br> - Known human epidermal growth factor receptor 2 (HER2) positive<br><br> - Untreated or symptomatic central nervous system (CNS) disease or brain metastases.<br><br> - Peripheral sensory neuropathy greater than or equal to Grade 2.<br><br> - Clinically significant cardiac disease.<br><br> - Other malignancy within the last 2 years (exceptions for definitively treated<br> disease).<br><br> - Chronic or systemic ophthalmological disorders.<br><br> - Major surgery or other investigational study within 28 days of first study treatment<br> dose.<br><br> - Palliative radiotherapy within 14 days of first study treatment dose.<br><br> - Abnormalities of the cornea that may pose an increased risk of developing a corneal<br> ulcer.<br><br> - History or evidence of systemic disease or ophthalmological disorders requiring<br> chronic use of ophthalmic corticosteroids.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT);Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE);Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Secondary Outcome Measures
Name Time Method Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab;Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab;Part 1: Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab;Part 1: OR per RECIST v1.1;Part 1: Duration of Response (DoR) per RECIST v1.1;Part 1: Disease Control Rate (DCR);Part 1: Progression-free Survival (PFS) per RECIST v1.1;Part 1: Overall Survival (OS);Part 2: Number of Participants Who Experience TEAEs;Part 2: DoR per RECIST v1.1;Part 2: Time to Response (TTR) per RECIST v1.1;Part 2: Disease Control (DC) per RECIST v1.1;Part 2: PFS per RECIST v1.1;Part 2: OS