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Clinical Trial Summary

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. The aims of the study are: - to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab. - to assess the effects of TAK-500, when given alone and when given with pembrolizumab, on adults with locally advanced or metastatic solid tumors. Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.


Clinical Trial Description

The drug being tested in this study is called TAK-500. The study will evaluate the safety, tolerability, antitumor activity, pharmacokinetics (PK), and pharmacodynamics of TAK-500 when used as a single agent (SA) and in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors. The study will be conducted in 2 phases: Dose Escalation and Dose Expansion Phase. The study will enroll approximately 106 participants (approximately 72 in the Dose Escalation Phase and approximately 34 in Dose Expansion Phase). The dose escalation phase will determine the recommended dose of TAK-500 along with the combination agents for the dose expansion phase. All the participants will be assigned to one of the 3 cohorts: - TAK-500 Single Agent (SA) (dosed Q3W) - Dose Escalation: TAK-500 (dosed Q3W) + Pembrolizumab (dosed Q3W) - Dose Expansion: TAK-500 (dosed Q3W and/or Q2W) + Pembrolizumab (dosed Q3W) This multi-center trial will be conducted in the United States. Participants with demonstrated clinical benefit may continue treatment beyond 1 year if approved by the sponsor. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05070247
Study type Interventional
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date November 17, 2021
Completion date April 8, 2025

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