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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Ikena Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma
• Urothelial Carcinoma Bladder
• Bladder Cancer
• Bladder Disease
• Solid Tumor
• Solid Carcinoma
• Solid Tumor, Adult
• Metastatic Cancer
• Advanced Solid Tumor
• Advanced Cancer
• Metastatic Bladder Cancer
• Metastatic Urothelial Carcinoma
• Locally Advanced Solid Tumor
• Neoplasms
• Neoplasm Metastasis
• Neoplasm Malignant
• Neoplasm, Bladder
• Urothelial Neoplasm
• Neoplasm, Urinary Bladder
• Bladder Neoplasm
• Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	IK-175	Subjects will be administered IK-175 PO daily for every 21-day treatment cycle during the Single Agent Treatment dose escalation or for every 28-day treatment cycle during the Single Agent dose expansion.
DRUG	IK-175 and nivolumab	Subjects will be administered IK-175 PO daily and administered a single dose of nivolumab IV on Day 1 for every 28-day treatment cycle during the Combination Treatment dose escalation and expansion.

Timeline

• Start date: 2019-12-18
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2019-12-16
• Last updated: 2024-03-15

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study