A Phase I Study of IK-175 in People with Advanced Urothelial Cancers

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Full 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

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy IK-175 in people with inoperable or metastatic bladder and other urothelial cancers that cannot be successfully treated with standard therapies. IK-175 works with the immune system to attack cancer cells.

IK-175 blocks a protein called AHR, which acts as a protective shield that prevents cancer cells from being recognized by the immune system. IK-175 attaches to AHR and breaks through the shield, activating the immune system to detect and destroy cancer cells. In addition to preventing AHR from hampering the immune system, researchers believe that IK-175 may have direct effects on cancer cells. IK-175 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic bladder cancer or another urothelial cancer that cannot be successfully treated with standard therapies.
  • Patients must recover from the serious side effects of previous treatments before receiving IK-175.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. David Aggen at 646-422-4679.

Protocol

20-472

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators