Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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 1,510-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (78% lower). The trial reports 15 study locations across 13 states.
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.
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,510-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (78% lower). The listed sponsor is IDEAYA Biosciences, which has 10 total studies on file at ClinicalTrials.gov.
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 reports 15 study locations spanning 13 distinct geographic areas - top geographies include 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
Similar trials for Colorectal Cancer
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.
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.