Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
← catalyst calendarNCT03947385 · readout in 163 d
Sponsored by IDEAYA Biosciences (industry) · IDYA — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
336estimated
Sites
15
Countries
Australia, Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-06-28 | actual | When the study began enrolling |
| Primary completion | 2027-01-29 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-15 | estimated | The whole study's end, after follow-up |
| First posted | 2019-05-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Metastatic Uveal Melanoma
- Cutaneous Melanoma
- Colorectal Cancer
- Other Solid Tumors
Interventions
- Drug: IDE196 — also filed as Protein Kinase C (PKC) Inhibitor
- Drug: Binimetinib — also filed as MEKTOVI
- Drug: Crizotinib — also filed as XALKORI
Primary outcomes
what the primary-completion date above is the date OFDose-limiting Toxicity (DLT)
measured 28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Incidence of Adverse Events
measured Approx. 8 months
Maximum Tolerated Dose (MTD)
measured 28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
Recommended Phase 2 Dose (RP2D) as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
measured Approx. 6 months
Plasma Concentrations of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib
measured Approx. 6 months
Plasma Concentrations of Crizotinib administered in combination with IDE196
measured Approx. 6 months
Plasma Concentrations of Binimetinib administered in combination with IDE196
measured Approx. 6 months
Overall Response Rate (ORR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessment
measured Approx. 8 months
Duration of Response (DOR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessment
measured Approx. 8 months
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