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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07730021). This is a study registration, not published results. Lead sponsor: Astellas Pharma Global Development, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 392 participants (ESTIMATED). Conditions: Locally Advanced or Metastatic Solid Tumors. Interventions: DRUG: ASP388B; DRUG: Pembrolizumab; DRUG: Carboplatin; DRUG: Oxaliplatin; DRUG: 5-fluorouracil. Primary outcome measures: Number of Participants with Dose Limiting Toxicities (DLTs) , Up to 21 days after C1D1; Number of Participants with Treatment-Emergent Adverse Events (TEAEs) , Up to 45 months; Number of participants with laboratory value abnormalities and/or adverse events (AEs) , Up to 45 months; Number of participants with vital sign abnormalities and/or AEs , Up to 45 months; Number of participants with electrocardiogram (ECG) abnormalities and/or AEs , Up to 45 months; Number of Participants with Physical Examination (PE) abnormalities and/or AEs , Up to 45 months; Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score , Up to 45 months. Brief summary: This is an early development study of ASP388B in people with solid tumors. In this study, ASP388B will be given to people for the first time. It will be given by itself or together with standard cancer therapies. The main aims of the study are to check the safety of ASP388B and find the most suitable dose. This study will be in 2 parts. In Part 1, different small groups of people with solid tumors will receive lower to higher doses of ASP388B. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies. Any medical problems will be recorded for each dose. This is to find suitable doses of ASP388B to use in Part 2 of the study, and to include the tumor types that responded well to ASP388B. In Part 2, other different small groups of people with the specific tumor types (from Part 1) will receive the most suitable doses worked out from Part 1. Some groups will receive ASP388B by itself, and other groups will receive ASP388B with standard cancer therapies. In both parts of the study, ASP388B will be given once in 3-week cycles. The standard cancer therapies will be given according to their approved label. ASP388B and the standard cancer therapies will be given slowly through a tube into a vein. This is called an infusion. In both parts of the study, safety checks will be done at each visit, and the doctors will continue to check for medical problems throughout the study.