Condition: Metastatic Uveal Melanoma · Cutaneous Melanoma · Colorectal Cancer · Sponsor: IDEAYA Biosciences
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…
This description comes directly from the study's public registry record.
IDEAYA Clinical Trials · 855-IDEA-BIO (855-433-2246) · IDEAYAClinicalTrials@ideayabio.com
Always discuss trial participation with your own doctor first.
| UCLA Medical Center | Los Angeles, California, United States | Recruiting |
| San Francisco Oncology Associates | San Francisco, California, United States | Active Not Recruiting |
| SCRI - Denver | Denver, Colorado, United States | Recruiting |
| University of Iowa | Iowa City, Iowa, United States | Active Not Recruiting |
| Cancer Hematology Centers Western Michigan | Grand Rapids, Michigan, United States | Active Not Recruiting |
| Columbia University Medical Center - Herbert Irving Pavilion | New York, New York, United States | Active Not Recruiting |
| Duke University Medical Center | Durham, North Carolina, United States | Recruiting |
| University of Cincinnati Cancer Center | Cincinnati, Ohio, United States | Recruiting |
| The Cleveland Clinic Foundation | Cleveland, Ohio, United States | Active Not Recruiting |
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia, Pennsylvania, United States | Recruiting |
| The Sarah Cannon Research Institute/Tennessee Oncology | Nashville, Tennessee, United States | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03947385