Actively Recruiting
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Led by IDEAYA Biosciences · Updated on 2026-01-27
336
Participants Needed
15
Research Sites
415 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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, cutaneous melanoma, colorectal cancer, or other solid tumors with GNAQ/11 mutations or PRKC fusions
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Expected life expectancy greater than 3 months
- Adequate organ function at screening
- Use of adequate contraceptive measures for non-sterilized males and females of childbearing potential
- For crizotinib combination: prior chemotherapy or major surgery completed at least 4 weeks before starting treatment
- For crizotinib combination: preexisting peripheral neuropathy of Grade 1 or lower
- For crizotinib combination: accessible lesion(s) allowing at least two biopsies without significant procedural risk
You will not qualify if you...
- Previous treatment with a PKC inhibitor
- Known MSI-H/dMMR tumors without prior immune checkpoint inhibitor therapy
- Known symptomatic brain metastases
- Unresolved adverse events from previous 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 other significant gastrointestinal disorder
- Females who are pregnant or breastfeeding
- Impaired cardiac function
- Use of prohibited medications that cannot be stopped before study entry
- Allergy to mammalian meat products or gelatin (for IDE196 powder-in-capsule or crizotinib recipients)
- For crizotinib combination: prior therapy targeting ALK, MET, or ROS1
- For crizotinib combination: spinal cord compression
- For crizotinib combination: history of pneumonitis or interstitial lung disease
- For crizotinib combination: history of syncope
- For crizotinib combination: thromboembolic or cerebrovascular events within 12 weeks prior to first dose
- PK substudy: recent use of statins or certain inhibitors, active liver disease, or contraindications to statins
- DDI cocktail substudy: recent use of specific drugs or supplements interfering with study medications
AI-Screening
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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
CONTACT
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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