First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer
Status:
Not yet recruiting
Trial end date:
2026-07-01
Target enrollment:
Participant gender:
Summary
The main aim of this study is to find out the safety and tolerability of TAK- 280 in
participants with unresectable, locally advanced or metastatic cancer failing or intolerant
to standard therapies. The study consists of a dose-escalation phase to determine the
recommended dose of TAK-280 for the cohort-expansion phase. Cohort-expansion phase will
further define the safety and initial efficacy of TAK-280.
Participants will be treated with TAK-280 for up to 14 treatment cycles for a maximum total
of 56 doses of TAK-280. Each treatment cycle will be 28 days. Participants will be treated
with TAK- 280 until disease progression, unacceptable toxicity, or withdrawal from study
occurs. Their cancer will be treated by their doctor according to their doctor's usual
clinical practice.
After the last dose of study drug, participants will be followed up for survival every 12
weeks for at least 52 weeks.