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RECRUITING
NCT03947385
PHASE1/PHASE2

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Sponsor: IDEAYA Biosciences

View on ClinicalTrials.gov

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

DRUG

IDE196

IDE196 dosed orally, twice daily for each 28-day cycle

DRUG

Binimetinib

Binimetinib dosed orally, twice daily for each 28-day cycle

DRUG

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