Trial · NCT03947385
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
NCT03947385, Phase 1, Phase 2, Recruiting, IDEAYA Biosciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions. Trials, record NCT03947385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03947385
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
- NCT number
- NCT03947385
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 336 participants, estimated
- Lead sponsor
- IDEAYA Biosciences
- Conditions
- Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer, Other Solid Tumors
- Interventions
- IDE196, Binimetinib, Crizotinib
- First posted
- 2019-05-13
- Last updated
- 2026-06-08
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting Toxicity (DLT) | 28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib | Determine DLT of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Incidence of Adverse Events | Approx. 8 months | Safety and tolerability of IDE196 either as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Maximum Tolerated Dose (MTD) | 28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib | Determine MTD of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Recommended Phase 2 Dose (RP2D) as monotherapy, in combination with Binimetinib, or in combination with Crizotinib | Approx. 6 months | Determine RP2D of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Plasma Concentrations of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib | Approx. 6 months | Pharmacokinetics of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib |
| Primary | Plasma Concentrations of Crizotinib administered in combination with IDE196 | Approx. 6 months | Pharmacokinetics of Crizotinib in combination with IDE196 |
| Primary | Plasma Concentrations of Binimetinib administered in combination with IDE196 | Approx. 6 months | Pharmacokinetics of Binimetinib in combination with IDE196 |
| Primary | Overall Response Rate (ORR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessment | Approx. 8 months | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria |
| Primary | Duration of Response (DOR) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessment | Approx. 8 months | RECIST v1.1 |
| Secondary | Progression Free Survival (PFS) of IDE196 monotherapy, in combination with Binimetinib, and in combination with Crizotinib in Dose Expansion cohorts by Investigator response assessment | Approx. 18 months | RECIST v1.1 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03947385
GET https://conductscience.org/api/trials/v1/NCT03947385/registered?page=2