First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
This study is one single group of participants with non-small cell lung cancer (NSCLC) who
have not been cured by other treatments. It is the first time the drug has been used in
humans, and will be in two parts.
The primary purpose of the parts are:
- Dose Escalation: To investigate the safety and tolerability and to determine the maximum
tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a
- Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional
solid tumors
This study is expected to last approximately 6 years from the time the first participant is
enrolled to the time the last subject is off the study. Study sites are located in both the
United States and Japan.
The number of treatment cycles is not fixed in this study. Participants who continue to
benefit from the study treatment may continue, unless:
- they withdraw
- their disease gets worse
- they experience unacceptable side effects.