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NCT03947385 · ClinicalTrials.gov registry record · Phase 1
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
A Phase 1 study of Colorectal Cancer and Cutaneous Melanoma, sponsored by IDEAYA Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 336
- Enrollment target
- 15
- Study locations
NCT03947385: Recruiting Phase 1 study of Colorectal Cancer and Cutaneous Melanoma, sponsored by IDEAYA Biosciences.
NCT03947385 is a Phase 1 study of Colorectal Cancer and Cutaneous Melanoma that is actively recruiting participants, run by IDEAYA Biosciences. The registered enrollment target is 336 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (78% lower). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03947385, a Phase 1 study of Colorectal Cancer and Cutaneous Melanoma, is actively recruiting participants, sponsored by IDEAYA Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 336 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study. Crizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity. As of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.
Primary Outcome
Determine DLT of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Conditions Studied
Interventions
- DRUG IDE196
- DRUG Binimetinib
- DRUG Crizotinib
Study Locations (15)
California
- UCLA Medical Center - Los Angeles
- San Francisco Oncology Associates - San Francisco
Ohio
- University of Cincinnati Cancer Center - Cincinnati
- The Cleveland Clinic Foundation - Cleveland
Colorado
- SCRI - Denver - Denver
Iowa
- University of Iowa - Iowa City
Michigan
- Cancer Hematology Centers Western Michigan - Grand Rapids
New York
- Columbia University Medical Center - Herbert Irving Pavilion - New York
North Carolina
- Duke University Medical Center - Durham
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2019-06-28 |
| Est. Completion | 2027-06-15 |
| Phase | Phase 1 |
What NCT03947385 shows while recruiting
NCT03947385 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (78% lower).
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which IDE196 is the first listed.
NCT03947385 lists 15 locations in 13 states (California, Ohio, Colorado).
Frequently Asked Questions
What is clinical trial NCT03947385 about?
NCT03947385 is a clinical study titled "Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions". This is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, an...
What is the current status of trial NCT03947385?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 336 participants. The study started on 2019-06-28. Estimated completion is 2027-06-15.
What conditions does trial NCT03947385 study?
This clinical trial studies the following conditions: Colorectal Cancer, Cutaneous Melanoma, Metastatic Uveal Melanoma, Other Solid Tumors.
What interventions are being tested in trial NCT03947385?
The interventions under investigation include: IDE196 (DRUG), Binimetinib (DRUG), Crizotinib (DRUG).
Who is sponsoring clinical trial NCT03947385?
This trial is sponsored by IDEAYA Biosciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03947385 being conducted?
This trial has 15 study locations across California, Colorado, Iowa, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03947385's enrollment target sits among peer trials
336 103rd of 381 higher than 279 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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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