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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    254
  • sponsor
    IDEAYA Biosciences
Updated on 25 May 2022
cancer
measurable disease
solid tumour
malignant melanoma of skin

Summary

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 study.

Phase 1 Tablet and Food Effect Pharmacokinetic (PK) Substudy will assess the PK profile of IDE196 tablet and evaluate the effects of food on the PK profile of IDE196 tablet

Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib 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.

Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib 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.

Details
Condition Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer, Other Solid Tumors
Treatment Crizotinib, Binimetinib, IDE196
Clinical Study IdentifierNCT03947385
SponsorIDEAYA Biosciences
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

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 and expected life expectancy of > 3 months
Adequate organ function at screening
Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential
Binimetinib Combination Additional Inclusion Criteria
• Adequate cardiac function represented by left ventricular ejection fraction
(LVEF) ≥ 50%
Crizotinib Combination Additional Inclusion Criteria
Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib
Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib

Exclusion Criteria

Previous treatment with a PKC inhibitor
Adverse events from prior anti-cancer therapy that have not resolved
Known symptomatic brain metastases
Recent surgery or radiotherapy
Females who are pregnant or breastfeeding
Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors
Impaired cardiac function
Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus
Binimetinib Combination Additional Exclusion Criteria
Active infection requiring ongoing therapy
History of interstitial lung disease
Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect
For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin
Allergy to binimetinib or its components
Treatment with prohibited medications that cannot be discontinued prior to study entry
Prior treatment with a MEK inhibitor
History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
Concurrent neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK)
History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to first dose
Uncontrolled arterial hypertension despite medical treatment
Crizotinib Combination Additional Exclusion Criteria
Prior therapy directly targeting ALK, MET, or ROS1
Spinal cord compression
History of syncope
History of pneumonitis or interstitial lung disease
History of syncope
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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