Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Start Date
6/28/2019
Completion Date
6/15/2027
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 (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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
IDE196
Binimetinib
Crizotinib
Conditions
Locations
UCLA Medical Center
Los Angeles, California 90095
United States
San Francisco Oncology Associates
San Francisco, California 94115
United States
SCRI - Denver
Denver, Colorado 80218
United States
University of Iowa
Iowa City, Iowa 52242
United States
Cancer Hematology Centers Western Michigan
Grand Rapids, Michigan 49503
United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
University of Cincinnati Cancer Center
Cincinnati, Ohio 45267
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Westmead Hospital
Sydney, New South Wales
Australia
Queensland
Woolloongabba, 4102
Australia
Princess Margaret Cancer Centre
Toronto, Ontario OPG 7-815
Canada