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NCT04200963 · ClinicalTrials.gov registry record · Phase 1
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 1 study of Solid Tumor and Advanced Solid Tumor, sponsored by Ikena Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 10
- Study locations
NCT04200963: Completed Phase 1 study of Solid Tumor and Advanced Solid Tumor, sponsored by Ikena Oncology.
NCT04200963 is a Phase 1 study of Solid Tumor and Advanced Solid Tumor that has completed, run by Ikena Oncology. The registered enrollment target is 78 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (65% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04200963, a Phase 1 study of Solid Tumor and Advanced Solid Tumor, has completed, sponsored by Ikena Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Proportion of adverse events (AEs) meeting protocol-defined DLT criteria
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 |
What the finished NCT04200963 record still lists
NCT04200963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (65% lower).
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.
NCT04200963 lists 10 locations in 9 states (Pennsylvania, Arizona, Florida).
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.
What interventions are being tested in trial NCT04200963?
The interventions under investigation include: IK-175 (DRUG), IK-175 and nivolumab (DRUG).
Who is sponsoring clinical trial NCT04200963?
This trial is sponsored by Ikena Oncology, which has 5 total clinical trials registered on ClinicalTrials.gov.
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
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04200963's enrollment target sits among peer trials
78 100th of 196 higher than 97 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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