OncoMatch/Clinical Trials/NCT03947385
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Is NCT03947385 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including IDE196 and Binimetinib for metastatic uveal melanoma.
Treatment: IDE196 · Binimetinib · Crizotinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Melanoma
Colorectal Cancer
Tumor Agnostic
Biomarker criteria
Required: GNAQ mutation
solid tumors harboring GNAQ/11 mutations
Required: GNA11 mutation
solid tumors harboring GNAQ/11 mutations
Required: PRKCA fusion
solid tumors harboring...PRKC fusions
Required: PRKCB fusion
solid tumors harboring...PRKC fusions
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PKC inhibitor
Previous treatment with a PKC inhibitor
Cannot have received: ALK inhibitor
Prior therapy directly targeting ALK
Cannot have received: MET inhibitor
Prior therapy directly targeting...MET
Cannot have received: ROS1 inhibitor
Prior therapy directly targeting...ROS1
Lab requirements
Blood counts
Adequate organ function at screening
Kidney function
Adequate organ function at screening
Liver function
Adequate organ function at screening
Adequate organ function at screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Medical Center · Los Angeles, California
- San Francisco Oncology Associates · San Francisco, California
- SCRI - Denver · Denver, Colorado
- University of Iowa · Iowa City, Iowa
- Cancer Hematology Centers Western Michigan · Grand Rapids, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03947385 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PKC inhibitor, ALK inhibitor, MET inhibitor disqualifies patients from enrollment.
Does this trial require GNAQ?
Yes, GNAQ mutation is a required biomarker for enrollment.
Does this trial require GNA11?
Yes, GNA11 mutation is a required biomarker for enrollment.
Does this trial require PRKCA?
Yes, PRKCA fusion is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages