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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants with Dose Limiting Toxicities (DLTs)
Timeframe: Up to 21 days after C1D1
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to 45 months
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Timeframe: Up to 45 months
Number of participants with vital sign abnormalities and/or AEs
Timeframe: Up to 45 months
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Timeframe: Up to 45 months
Number of Participants with Physical Examination (PE) abnormalities and/or AEs
Timeframe: Up to 45 months
Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score
Timeframe: Up to 45 months
Astellas Pharma Global Development, Inc.