NCT03947385 · IDEAYA Biosciences
Study of IDE196 in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
What this study is about
This is a Phase 1/2, multi-center, where both patients and doctors know the treatment given 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.
View original scientific description
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.
Interventions
DRUG
IDE196
IDE196 dosed orally, twice daily for each 28-day cycle
DRUG
Binimetinib
Binimetinib dosed orally, twice daily for each 28-day cycle
DRUG
Crizotinib
Crizotinib dosed orally, twice daily for each 28-day cycle
Primary outcome measures
Dose-limiting Toxicity (DLT)
Time frame: 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 Events
Time frame: Approx. 8 months
Safety and tolerability of IDE196 either as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Maximum Tolerated Dose (MTD)
Time frame: 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 Crizotinib
Time frame: Approx. 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 Crizotinib
Time frame: Approx. 6 months
Pharmacokinetics of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Plasma Concentrations of Crizotinib administered in combination with IDE196
Time frame: Approx. 6 months
Pharmacokinetics of Crizotinib in combination with IDE196
Plasma Concentrations of Binimetinib administered in combination with IDE196
Time frame: Approx. 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 assessment
Time frame: Approx. 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 assessment
Time frame: Approx. 8 months
RECIST v1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
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
- For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin Crizotinib Combination Additional Exclusion Criteria:
- 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 PK Substudy (optional) with Pravastatin Additional Exclusion Criteria:
- 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 DDI Cocktail Substudy Additional Exclusion Criteria:
- 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.
Where
- Los Angeles, California
- San Francisco, California
- Denver, Colorado
- Iowa City, Iowa
- Grand Rapids, Michigan
- New York, New York
- Durham, North Carolina
- Cincinnati, Ohio
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations