The trial at a glance
OptimUM-01 is designed to evaluate the safety and anti-tumor activity of darovasertib in patients with solid tumors harboring GNAQ/11 mutations or PKC fusions.1
Dose escalation (phase 1)
Dose expansion (phase 2)
Dose escalation (phase 1)
Dose expansion (phase 2)
Additional patient criteria for crizotinib combination only
- HLA-A*02:01-positive mUM
Dose escalation (phase 1)
Dose expansion (phase 2)*
Dose optimization (phase 2)
*Dose expansion (phase 2) includes a pharmacokinetics substudy.1
Primary endpoints
As monotherapy and in combination1
- Dose-limiting toxicity
- Maximum tolerated dose
- Recommended phase 2 dose
- Pharmacokinetics of darovasertib as monotherapy and in combination with binimetinib or crizotinib, as well as binimetinib or crizotinib in combination with darovasertib
In combination only1
- Overall response rate
- Duration of response
SELECT INCLUSION CRITERIA1
- Age 18 years or older
- Uveal melanoma with histologically or cytologically confirmed metastatic disease (patients may be treatment naive or have progressed on or after most recent therapy)
- ECOG performance status ≤1 and life expectancy of >3 months
- For the HLA-A*02:01 positive cohort:
- Documented HLA status via test results from a CAP/CLIA-certified laboratory
SELECT EXCLUSION CRITERIA1
- Previous treatment with a PKC inhibitor
- Known MSI-H/dMMR tumors in patients who have not previously received immune checkpoint inhibitors
- Known symptomatic brain metastases
- Adverse events from prior anti-cancer therapy that have not resolved
- Known AIDS-related illness, hepatitis B virus, or hepatitis C virus
- Active infection requiring ongoing therapy
- Recent surgery or radiotherapy
- Any gastrointestinal disorder or defect
- Impaired cardiac function
- Crizotinib combination only:
- Prior therapy directly targeting ALK, MET, or ROS1
- Spinal cord compression
- History of pneumonitis, interstitial lung disease, or syncope
- History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment
BID, twice daily; CAP, College of American Pathologists; CLIA, Clinical Laboratory Improvement Amendments; dMMR, deficient mismatch repair; ECOG, Eastern Cooperative Oncology Group; HLA, human leukocyte antigen; HLA-A*02:01, human leukocyte antigen A02:01 major histocompatibility complex class I allele; MSI-H, microsatellite instability-high; mUM, metastatic uveal melanoma; PKC, protein kinase C.
Trial site locations
OptimUM-01 is available globally. Browse below to view participating sites.
New South Wales, Australia
Westmead Hospital
Sydney, NSW 2145
Ontario, Canada
Princess Margaret Cancer Centre
Toronto, ON, OPG 7-815
California, United States
UCLA Medical Center
Los Angeles, CA 90095
California, United States
San Francisco Oncology Associates
San Francisco, CA 94115
New York, United States
Columbia University Medical Center – Herbert Irving Pavilion
New York, NY 10032
North Carolina, United States
Duke University Medical Center
Durham, NC 27710
Ohio, United States
University of Cincinnati Cancer Center
Cincinnati, OH 45267
Pennsylvania, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, PA 19107
Tennessee, United States
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, TN 37203
Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, TX 77030
See more
Contact IDEAYA Clinical Trials to learn more.
Get in TouchDarovasertib is an investigational product and has not been approved by the U.S. Food and Drug Administration for safety or effectiveness.
Reference: 1. Study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions. ClinicalTrials.gov identifier: NCT03947385. Updated November 13, 2024. Accessed January 14, 2026. https://clinicaltrials.gov/study/NCT03947385