Back to search results

Study of IDE196 for Solid Tumors with GNAQ/11 Mutations or PRKC Fusions

This study is testing a drug called IDE196, alone or with other drugs (Binimetinib or Crizotinib), for people with certain solid tumors. These tumors must have specific genetic changes called GNAQ/11 mutations or PRKC fusions. The study includes metastatic uveal melanoma (a type of eye cancer that has spread), cutaneous melanoma (skin cancer), colorectal cancer, and other solid tumors. Researchers want to find out how safe IDE196 is, what dose works best, and if it can shrink tumors. You would need to be at least 18 years old and have one of these tumor types with the specific genetic changes to join. The study is currently enrolling up to 336 participants.

Study design
This is a Phase 1/2, multi-center, open-label study, meaning both you and your doctors will know which treatment you are receiving. It aims to enroll up to 336 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for approximately 8 months. Dose-limiting toxicity and maximum tolerated dose will be measured 28 days after the first dose of IDE196.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03947385

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Recruiting
PHASE1Ages 18+InterventionalTreatment
IDEAYA Biosciences
~336 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:IDE196BinimetinibCrizotinib

At a glance

Recruiting sites
7 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting Toxicity (DLT)
Measured over 28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
+8 more outcomes measured

Conditions

Metastatic Uveal Melanoma
Cutaneous Melanoma
Colorectal Cancer
Other Solid Tumors

Explore related trials

Colorectal CarcinomaCutaneous MelanomaSolid NeoplasmUveal MelanomaGNA11 GeneGNAQ GenePRKCA Gene

Where it's being run

15 sites across 13 states
California2
Ohio2
Colorado1
Iowa1
Michigan1
New York1
North Carolina1
Pennsylvania1

Study leadership

Who to contact

IDEAYA Clinical Trials
[email protected]
855-IDEA-BIO (855-433-2246)
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patient must be ≥18 years of age and able to provide written informed consent
Diagnosis of the following:
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
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.

Exclusion

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
For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin
Prior therapy directly targeting ALK, MET, or ROS1
Spinal cord compression
History of pneumonitis or interstitial lung disease
History of syncope
History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment
Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollment in the study and cannot refrain from them through C2D1
Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin
Any contraindication associated to the use of statins or hypersensitivity component of pravastatin
Active liver disease
Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1.
Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit/grapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1.
Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.
Moderate and strong inhibitors of CYP2A4/5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.
Intake of strong or moderate inducers of CYP3A4/5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1.

What this trial measures

  • Dose-limiting Toxicity (DLT)28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib

    Determine DLT of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib

  • Incidence of Adverse EventsApprox. 8 months

    Safety and tolerability of IDE196 either as monotherapy, in combination with Binimetinib, or in combination with Crizotinib

  • Maximum Tolerated Dose (MTD)28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib

    Determine MTD of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib

  • Recommended Phase 2 Dose (RP2D) as monotherapy, in combination with Binimetinib, or in combination with CrizotinibApprox. 6 months

    Determine RP2D of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib

  • Plasma Concentrations of IDE196 as monotherapy, in combination with Binimetinib, or in combination with CrizotinibApprox. 6 months

    Pharmacokinetics of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib

  • Plasma Concentrations of Crizotinib administered in combination with IDE196Approx. 6 months

    Pharmacokinetics of Crizotinib in combination with IDE196

  • Plasma Concentrations of Binimetinib administered in combination with IDE196Approx. 6 months

    Pharmacokinetics of Binimetinib in combination with IDE196

  • Overall Response Rate (ORR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessmentApprox. 8 months

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria

  • Duration of Response (DOR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessmentApprox. 8 months

    RECIST v1.1