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Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Sponsor: IDEAYA Biosciences
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.
Official title: A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2019-06-28
Completion Date
2027-06-15
Last Updated
2026-01-27
Healthy Volunteers
No
Interventions
IDE196
IDE196 dosed orally, twice daily for each 28-day cycle
Binimetinib
Binimetinib dosed orally, twice daily for each 28-day cycle
Crizotinib
Crizotinib dosed orally, twice daily for each 28-day cycle
Locations (15)
UCLA Medical Center
Los Angeles, California, United States
San Francisco Oncology Associates
San Francisco, California, United States
SCRI - Denver
Denver, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
Cancer Hematology Centers Western Michigan
Grand Rapids, Michigan, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Westmead Hospital
Sydney, New South Wales, Australia
Queensland
Woolloongabba, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada