Who is eligible for clinical trial NCT03947385?

Participants must meet the protocol's inclusion criteria for Metastatic Uveal Melanoma. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03947385 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-04

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

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: IDEAYA Biosciences

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (27 items).

Location: UCLA Medical Center — Los Angeles, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patient must be ≥18 years of age and able to provide written informed consent
Diagnosis of the following: o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed on or after most recent therapy. If the most recent therapy was an immune-oncology agent, PD must be confirmed. \- If a patient is treatment naïve and human leukocyte antigen (HLA)-A\*02:01 positive\*\*\*, documentation is required to provide rationale why treatment with tebentafusp is not the ideal firstline treatment approach or of the patient's intolerance to tebentafusp. \*\*\*To be enrolled in the HLA-A\*02:01 positive cohort, HLA status must be documented by test results from a CAP/CLIA-certified laboratory.
Measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group ≤1 and expected life expectancy of \> 3 months
Adequate organ function at screening
Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential Crizotinib Combination Additional Inclusion Criteria:
Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib
Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib Biopsy-eligible patients
Accessible lesion(s) that permit a total of at least two biopsies without unacceptable risk of a significant procedural complication.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Previous treatment with a PKC inhibitor
Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors
Known symptomatic brain metastases
Adverse events from prior anti-cancer therapy that have not resolved
Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus
Active infection requiring ongoing therapy
Recent surgery or radiotherapy
Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect
Females who are pregnant or breastfeeding
Impaired cardiac function
Treatment with prohibited medications that cannot be discontinued prior to study entry

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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

Tebentafusp-tebn With LDT in Metastatic UM — Philadelphia, Pennsylvania
Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma — Tampa, Florida
Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma — Los Angeles, California
Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma — Tampa, Florida
A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma — Scottsdale, Arizona

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.

🏛️ View Official NIH Record ↗