Status and phase
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About
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. 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Patient must be ≥18 years of age
Diagnosis of one of the following:
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:
Exclusion criteria
Binimetinib Combination Additional Exclusion Criteria
Crizotinib Combination Additional Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
278 participants in 9 patient groups
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Central trial contact
IDEAYA Clinical Trials
Data sourced from clinicaltrials.gov
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