drugset / Trial / NCT05070247

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

NCT05070247

Phase 1/2 Terminated 61 enrolled Takeda
Non-randomizedSequentialOpen-labelTreatment

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 anti-tumor effects of TAK-500, when given alone and when given with pembrolizumab, in 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.

Timeline

Start
2022-04-14
Primary completion
2025-01-06
Completion
2025-01-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject TAK-500 Unknown 8 ug/kg Intravenous
Subject TAK-500 Unknown 16 ug/kg Intravenous
Subject TAK-500 Unknown 24 ug/kg Intravenous
Subject TAK-500 Unknown 40 ug/kg Intravenous
Subject TAK-500 Unknown 60 ug/kg Intravenous
Background Dexamethasone Small molecule 10 mg Intravenous
Background Tocilizumab Monoclonal antibody 8 mg/kg Intravenous