The main aim of this study is to find out the safety, tolerability, and effect of TAK-
280 in participants with unresectable, locally advanced or metastatic cancer who have
experienced treatment failure or are intolerant to standard therapies.
Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment
cycle will be 28 days.
After the last dose of study drug, participants will be followed up for survival every 12
weeks for a total of 48 weeks.
Additional locations may be listed on ClinicalTrials.gov for NCT05220098.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Name Not Available
This study consists of 2 phases: Dose-escalation and cohort-expansion phase.
Dose-escalation phase:
The purpose of the dose-escalation phase is to generate data to characterize the initial
safety and tolerability profile of TAK-280 and determine the 2 recommended doses for
expansion (RDEs) of TAK-280 to be administered during the cohort-expansion phase.
Cohort-Expansion Phase:
The cohort expansion phase will be conducted in 3 indications. Only in 1 selected
indication participants will be randomized 1:1 to receive either TAK-280 high dose or low
dose. In the remaining 2 indications to be studied in the cohort-expansion phase,
participants will receive only one dose level of TAK-280.
Lead OrganizationTakeda USA Inc