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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

Neoplasms Clinical Trial

Official title:
A Phase 1a/b, Open-Label, Dose-Escalation and Expansion Study of IK-175, an Oral Aryl Hydrocarbon Receptor (AHR) Inhibitor, as a Single Agent and in Combination With Nivolumab, a PD-1 Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Advanced Cancer
  • Advanced Solid Tumor
  • Bladder Cancer
  • Bladder Disease
  • Bladder Neoplasm
  • Bladder Urothelial Carcinoma
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Locally Advanced Solid Tumor
  • Metastatic Bladder Cancer
  • Metastatic Cancer
  • Metastatic Urothelial Carcinoma
  • Neoplasm Malignant
  • Neoplasm Metastasis
  • Neoplasm, Bladder
  • Neoplasm, Urinary Bladder
  • Neoplasms
  • Solid Carcinoma
  • Solid Tumor
  • Solid Tumor, Adult
  • Urinary Bladder Diseases
  • Urinary Bladder Neoplasms
  • Urothelial Carcinoma
  • Urothelial Carcinoma Bladder
  • Urothelial Neoplasm
Clinical Trial Details
NCT number NCT04200963
Study type Interventional
Source Ikena Oncology
Contact
Status Completed
Phase Phase 1
Start date December 18, 2019
Completion date July 18, 2023
View Details
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