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

Recruiting now · Phase 1/Phase 2

Conditions studied: Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer, Other Solid Tumors

In brief

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.

Key facts

Study ID: NCT03947385
Run by: IDEAYA Biosciences
People needed: 336
Starts: 2019-06-28
Expected to finish: 2027-06-15
Last updated by the study team: 2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

UCLA Medical Center — Los Angeles, California, United States (enrolling)
SCRI - Denver — Denver, Colorado, United States (enrolling)
Duke University Medical Center — Durham, North Carolina, United States (enrolling)
University of Cincinnati Cancer Center — Cincinnati, Ohio, United States (enrolling)
Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
The Sarah Cannon Research Institute/Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Princess Margaret Cancer Centre — Toronto, Ontario, Canada
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
San Francisco Oncology Associates — San Francisco, California, United States
Westmead Hospital — Sydney, New South Wales, Australia
University of Iowa — Iowa City, Iowa, United States
Cancer Hematology Centers Western Michigan — Grand Rapids, Michigan, United States
Columbia University Medical Center - Herbert Irving Pavilion — New York, New York, United States
Queensland — Woolloongabba, Australia

Full record on ClinicalTrials.gov

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