Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions (NCT03947385)
A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCLA Medical Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- UCLA Medical Center — Los Angeles, California
- San Francisco Oncology Associates — San Francisco, California
- SCRI - Denver — Denver, Colorado
- University of Iowa — Iowa City, Iowa
- Cancer Hematology Centers Western Michigan — Grand Rapids, Michigan
- Columbia University Medical Center - Herbert Irving Pavilion — New York, New York
- Duke University Medical Center — Durham, North Carolina
- University of Cincinnati Cancer Center — Cincinnati, Ohio
- The Cleveland Clinic Foundation — Cleveland, Ohio
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania
- The Sarah Cannon Research Institute/Tennessee Oncology — Nashville, Tennessee
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Westmead Hospital — Sydney, New South Wales
- Queensland — Woolloongabba,
- Princess Margaret Cancer Centre — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: 855-IDEA-BIO (855-433-2246)
Email: IDEAYAClinicalTrials@ideayabio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Uveal Melanoma
- Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma — Tampa, Florida
- IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma — Scottsdale, Arizona
- Vorinostat in Treating Patients With Metastatic Melanoma of the Eye — New York, New York
- A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas — Boston, Massachusetts
- Tebentafusp-tebn With LDT in Metastatic UM — Philadelphia, Pennsylvania
Explore by condition: All Metastatic Uveal Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.