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Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
NCT03947385 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03947385
The ClinicalTrials.gov registry entry for NCT03947385 describes a study currently listed as recruiting. 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 336 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IDEAYA Biosciences, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT03947385 reports 15 study locations spanning 13 distinct geographic areas — top geographies include California, Ohio, Colorado. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03947385?
The interventions under investigation include: IDE196 (DRUG), Binimetinib (DRUG), Crizotinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03947385?
This trial is sponsored by IDEAYA Biosciences, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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