drugset / Trial / NCT04200963

A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma

NCT04200963

Phase 1 Completed 78 enrolled Ikena Oncology Bristol-Myers Squibb · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable. This is a phase 1, multi-center, open label study designed to assess safety and tolerability of IK-175 as a single agent and in combination with nivolumab, to determine the recommended phase 2 dose (RP2D). Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

Timeline

Start
2019-12-18
Primary completion
2023-07-18
Completion
2023-07-18

Drugs

EvaluationDrugModalityDoseRoute
Subject IK-175 Unknown Oral
Subject Nivolumab Monoclonal antibody Intravenous