First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer
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- STATUS
- Recruiting
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- End date
- Jul 1, 2026
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- participants needed
- 186
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- sponsor
- Takeda
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.
Description
This study consists of 2 phases: Dose-escalation and cohort-expansion phase.
Dose-escalation phase:
Dose escalation will be conducted in participants with histologically proven, unresectable, locally advanced or metastatic cancers and the Bayesian Optimal Interval (BOIN) design will be used.
Cohort-Expansion Phase:
During the cohort-expansion phase, 5 separate participant cohorts will be enrolled, based on the tumor type. The dosing regimen used in the expansion cohorts will be the recommended phase 2 dose (RP2D) and schedule based on the safety, pharmacokinetics (PK), and antitumor activity findings from the dose-escalation phase of the study.
Enrollment into the expansion cohorts is based on a Simon 2-stage design.
Details
| Condition | Unresectable Locally Advanced or Metastatic Cancer |
|---|---|
| Treatment | TAK-280 |
| Clinical Study Identifier | NCT05220098 |
| Sponsor | Takeda |
| Last Modified on | 15 May 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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