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

ClinicalTrials.gov ID: NCT04200963

Public ClinicalTrials.gov record NCT04200963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04200963
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Ikena Oncology; Industry
Enrollment: 78 participants

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 18, 2019 (Actual)
Primary completion: Jul 18, 2023 (Actual)
Completion: Jul 18, 2023 (Actual)
Last update posted: Mar 15, 2024

2019 – 2023

United States locations

U.S. sites: 10
U.S. states: 9
U.S. cities: 10

Facility	City	State	ZIP	Site status
Banner Health- MD Anderson Cancer Center	Gilbert	Arizona	85234	—
Florida Cancer Specialists - Sarasota	Sarasota	Florida	85234	—
Rush University Medical Center	Chicago	Illinois	60612	—
Johns Hopkins Kimmel Cancer Center	Baltimore	Maryland	21287	—
START Midwest	Grand Rapids	Michigan	49546	—
Memorial Sloan Kettering Cancer Center	New York	New York	10065	—
Sydney Kimmel Cancer Center Thomas Jefferson University	Philadelphia	Pennsylvania	19107	—
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	—
The Sarah Cannon Research Institute	Nashville	Tennessee	37203	—
MD Anderson Cancer Center	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04200963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 15, 2024 · Synced Oct 30, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04200963 live on ClinicalTrials.gov.

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