Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
a study on Melanoma Skin Cancer/Melanoma Colorectal Cancer Solid Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedestimated completion
Description
Summary
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 - 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.
Official Title
A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Keywords
Metastatic Uveal Melanoma Cutaneous Melanoma Colorectal Cancer Other Solid Tumors Melanoma IDE196 Binimetinib Dose Escalation Monotherapy Dose Expansion Monotherapy Tablet PK Substudy
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- Another malignancy
- Previous treatment with a PKC inhibitor
- Known microsatellite instability-high (MSI-H) tumors
- 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, 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 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 Kinase (CK)
- Allergy to binimetinib or its components
Locations
- UCLA Medical Center
accepting new patients
Los Angeles California 90095 United States - The University of Texas MD Anderson Cancer Center
accepting new patients
Houston Texas 77030 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- IDEAYA Biosciences
- ID
- NCT03947385
- Phase
- Phase 1/2
- Study Type
- Interventional
- Last Updated