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
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.
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
- Enrollment
- 78 participants
Conditions and interventions
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
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 17, 2019
- Primary completion
- Jul 17, 2023
- Completion
- Jul 17, 2023
- Last update posted
- Mar 14, 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 14, 2024 · Synced Sep 15, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04200963 live on ClinicalTrials.gov.