Actively Recruiting
A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Led by IDEAYA Biosciences · Updated on 2026-06-08
336
Participants Needed
15
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and anti-tumor activity of IDE196 in patients with solid tumors that have specific mutations in GNAQ or GNA11 genes or PRKC fusions. This includes metastatic uveal melanoma, cutaneous melanoma, colorectal cancer, and other solid tumors. The study is a Phase 1/2, multi-center, open-label trial designed to find the best dose and assess how well IDE196 works alone or combined with other drugs. The study involves different treatment groups: IDE196 given orally twice daily alone, IDE196 combined with Binimetinib, and IDE196 combined with Crizotinib, all administered in 28-day cycles. There are dose escalation phases to determine recommended doses and dose expansion phases to further assess safety and anti-tumor activity. Some patients receive Crizotinib alone initially and may cross over to combination therapy. Additional sub-studies evaluate drug interactions and pharmacokinetics with other medications. Participants will take oral study drugs twice daily and undergo regular safety and effectiveness evaluations, including measuring tumor response and drug levels in the blood. Safety monitoring covers dose-limiting toxicities, adverse events, and recommended dosing. The study also tracks progression-free survival and response duration over several months. Participation includes multiple visits for assessments, imaging, and laboratory tests over the study period, which may last several months to years based on treatment and follow-up needs.
CONDITIONS
Brief Title
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older and able to provide written informed consent
- Diagnosis of metastatic uveal melanoma with confirmed metastatic disease, cutaneous melanoma, colorectal cancer, or other solid tumors harboring GNAQ/11 mutations or PRKC fusions
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1 and expected life expectancy greater than 3 months
- Adequate organ function at screening
- Use of adequate contraceptive measures for non-sterilized male and female patients of childbearing potential
- For crizotinib combination cohorts, prior chemotherapy or major surgeries completed at least 4 weeks before starting crizotinib
- Patients with preexisting peripheral neuropathy of Grade 1 or lower are eligible for crizotinib combination
- Accessible lesions allowing at least two biopsies without significant risk
You will not qualify if you...
- Previous treatment with a PKC inhibitor
- Known microsatellite instability-high or mismatch repair deficient tumors without prior immune checkpoint inhibitor treatment
- Known symptomatic brain metastases
- Unresolved adverse events from prior anti-cancer therapy
- Known AIDS-related illness, hepatitis B or C infection
- Active infection requiring ongoing treatment
- Recent surgery or radiotherapy
- Prior gastrectomy, upper bowel removal, or significant gastrointestinal disorders
- Pregnant or breastfeeding females
- Impaired cardiac function
- Use of prohibited medications that cannot be stopped before study entry
- Allergy to mammalian meat products or gelatin (for patients receiving IDE196 powder-in-capsule or crizotinib)
- For crizotinib combination: prior therapy targeting ALK, MET, or ROS1
- Spinal cord compression
- History of pneumonitis or interstitial lung disease
- History of syncope
- History of thromboembolic or cerebrovascular events within 12 weeks before treatment
- For pravastatin PK substudy: recent statin use or contraindications to statins
- For drug interaction substudy: recent use of specific medications or supplements that affect drug metabolism or absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive oral doses of IDE196 alone or in combination with Binimetinib or Crizotinib, taken twice daily in 28-day cycles.
Visits occur regularly each cycle for dosing and assessments
Duration - Up to approximately 18 months after treatment
Participants are monitored for safety and treatment outcomes after ending the treatment.
Follow-up visits according to study schedule for monitoring
Trial Site Locations
Total: 15 locations
1
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
San Francisco Oncology Associates
San Francisco, California, United States, 94115
Active, Not Recruiting
3
SCRI - Denver
Denver, Colorado, United States, 80218
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
5
Cancer Hematology Centers Western Michigan
Grand Rapids, Michigan, United States, 49503
Active, Not Recruiting
6
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States, 10032
Active, Not Recruiting
7
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
8
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
9
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
10
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
11
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
Westmead Hospital
Sydney, New South Wales, Australia
Active, Not Recruiting
14
Queensland
Woolloongabba, Australia, 4102
Active, Not Recruiting
15
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, OPG 7-815
Active, Not Recruiting
Research Team
I
IDEAYA Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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