Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Status:
Recruiting
Trial end date:
2023-04-30
Target enrollment:
Participant gender:
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 - 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.