Houston, Texas 77030

  • Other Solid Tumors

Purpose:

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 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet 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.


Criteria:

Inclusion Criteria: - Patient must be ≥18 years of age - Diagnosis of one of the following: - MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Or - Non-MUM: Advanced cutaneous melanoma, colorectal cancer, or other solid tumor that has progressed following prior standard therapies or that has no satisfactory alternative therapies and has evidence of GNAQ/11 hotspot mutation - Measurable disease - 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 Binimetinib Combination Additional Inclusion Criteria: • Adequate cardiac function represented by left ventricular ejection fraction (LVEF) ≥ 50% 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 Exclusion Criteria: - Another malignancy - Previous treatment with a PKC inhibitor - Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors - Adverse events from prior anti-cancer therapy that have not resolved - Untreated or symptomatic central nervous system metastases - Human immunodeficiency virus, acquired immunodeficiency syndrome related illness, hepatitis B virus, or hepatitis C virus - Recent surgery or radiotherapy - Females who are pregnant or breastfeeding - Impaired cardiac function - For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin Binimetinib Combination Additional Exclusion Criteria - Patient has received prior treatment with a MEK inhibitor - History of interstitial lung disease - History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to first dose - History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO); History of retinal degenerative disease - Concurrent neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK) - Uncontrolled arterial hypertension despite medical treatment - Allergy to binimetinib or its components Crizotinib Combination Additional Exclusion Criteria: - Prior therapy directly targeting ALK, MET, or ROS1 - Spinal cord compression - Carcinomatous meningitis or leptomeningeal disease - History of pneumonitis or interstitial lung disease


NCT ID:

NCT03947385


Primary Contact:

IDEAYA Clinical Trials
Phone: +1 650 534 3616
Email: IDEAYAClinicalTrials@ideayabio.com


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Filip Janku, MD
Phone: 713-792-6161
Email: FJanku@mdanderson.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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