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

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 s

Trial Details

NCT ID
NCT03947385
Phase
PHASE1 / PHASE2
Sponsor
IDEAYA Biosciences
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • IDE196
  • Binimetinib
  • Crizotinib
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Denver, Colorado, United States|39.73915,-104.9847
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Grand Rapids, Michigan, United States|42.96336,-85.66809

Key Eligibility Criteria

  • Patient must be ≥18 years of age and able to provide written informed consent
  • Diagnosis of the following:
  • o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed o…
  • \- If a patient is treatment naïve and human leukocyte antigen (HLA)-A\*02:01 positive\*\*\*, documentation is required to provide rationale why tr…

For full eligibility, visit ClinicalTrials.gov.

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