Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT04200963 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG IK-175
- DRUG IK-175 and nivolumab
Study Locations (10)
Pennsylvania
- Sydney Kimmel Cancer Center Thomas Jefferson University — Philadelphia
- UPMC Hillman Cancer Center — Pittsburgh
Arizona
- Banner Health- MD Anderson Cancer Center — Gilbert
Florida
- Florida Cancer Specialists - Sarasota — Sarasota
Illinois
- Rush University Medical Center — Chicago
Maryland
- Johns Hopkins Kimmel Cancer Center — Baltimore
Michigan
- START Midwest — Grand Rapids
New York
- Memorial Sloan Kettering Cancer Center — New York
Tennessee
- The Sarah Cannon Research Institute — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2023-07-18 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04200963
The ClinicalTrials.gov registry entry for NCT04200963 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ikena Oncology, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which IK-175 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04200963 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Pennsylvania, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04200963 about?
NCT04200963 is a clinical study titled "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". 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 tolerab...
What is the current status of trial NCT04200963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2019-12-18. Estimated completion is 2023-07-18.
What conditions does trial NCT04200963 study?
This clinical trial studies the following conditions: Solid Tumor, Advanced Solid Tumor, Bladder Cancer, Advanced Cancer, Metastatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04200963?
The interventions under investigation include: IK-175 (DRUG), IK-175 and nivolumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04200963?
This trial is sponsored by Ikena Oncology, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04200963 being conducted?
This trial has 10 study locations across Arizona, Florida, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.