Clinical Trials /

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

NCT03947385

Description:

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) 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.

Related Conditions:
  • Colorectal Carcinoma
  • Cutaneous Melanoma
  • Malignant Solid Tumor
  • Uveal Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
  • Official Title: A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Clinical Trial IDs

  • ORG STUDY ID: IDE196-001
  • NCT ID: NCT03947385

Conditions

  • Metastatic Uveal Melanoma
  • Cutaneous Melanoma
  • Colorectal Cancer
  • Other Solid Tumors

Interventions

DrugSynonymsArms
IDE196Dose Escalation

Purpose

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) 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.

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalIDE196 dosed orally, twice daily (BID) for each 28-day cycle
  • IDE196
Dose ExpansionExperimentalRP2D
  • IDE196

Eligibility Criteria

        Inclusion Criteria:

          -  Patient must be ≥18 years of age

          -  Diagnosis of one of the following:

               -  MUM: Uveal melanoma with histological or cytological confirmed metastatic
                  disease. Or

               -  Non-MUM: Advanced cutaneous melanoma, colorectal cancer, or other solid tumor
                  that has progressed following prior standard therapies or that has no
                  satisfactory alternative therapies and has evidence of GNAQ/11 hotspot mutation

          -  Measurable disease

          -  Eastern Cooperative Oncology Group ≤1

          -  Adequate organ function at screening

          -  Adequate contraceptive measures for non-sterilized male and female patients of
             childbearing potential

        Exclusion Criteria:

          -  Another malignancy

          -  Known microsatellite instable - high (MSI-H) tumors

          -  Adverse events from prior anti-cancer therapy that have not resolved

          -  Untreated or symptomatic central nervous system metastases

          -  Human immunodeficiency virus, acquired immunodeficiency syndrome related illness,
             hepatitis B virus, or hepatitis C virus

          -  Recent surgery or radiotherapy

          -  Females who are pregnant or breastfeeding

          -  Impaired cardiac function
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting Toxicity (DLT)
Time Frame:28 days following first dose of IDE196
Safety Issue:
Description:Determine DLT of IDE196

Secondary Outcome Measures

Measure:Duration of Response
Time Frame:Approx. 30 months
Safety Issue:
Description:RECIST version 1.1
Measure:Disease Control
Time Frame:Approx. 30 months
Safety Issue:
Description:RECIST version 1.1
Measure:Numbers of Participants with Adverse Events
Time Frame:Approx. 48 months
Safety Issue:
Description:Safety and tolerability of IDE196

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:IDEAYA Biosciences

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