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

Launched by IDEAYA BIOSCIENCES · May 9, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called IDE196 to see how safe it is and how well it can help treat certain types of solid tumors, particularly those with specific genetic changes known as GNAQ or GNA11 mutations, or PRKC fusions. The types of cancer being looked at include metastatic uveal melanoma (a type of eye cancer), cutaneous melanoma (skin cancer), colorectal cancer, and other solid tumors. The study will involve different phases where the dosage of IDE196 will be adjusted to find the safest and most effective dose. Participants may also receive IDE196 in combination with other drugs to see if this helps improve treatment outcomes.

To be eligible for the trial, participants should be at least 18 years old and have a confirmed diagnosis of one of the targeted cancers that has not responded to standard treatments. They should have measurable disease and good overall health, with an expected life expectancy of more than three months. During the trial, participants will be closely monitored for any side effects and how well the treatment is working. It’s important to note that certain health conditions or prior treatments may exclude someone from participating, so potential candidates should discuss their individual situation with their doctor. Overall, this study aims to explore new treatment options for patients with challenging tumors, and participants will play a crucial role in advancing cancer research.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Patient must be ≥18 years of age and able to provide written informed consent
• * Diagnosis of the following:
• • o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed on or after most recent therapy. If the most recent therapy was an immune-oncology agent, PD must be confirmed.
• • - If a patient is treatment naïve and human leukocyte antigen (HLA)-A\*02:01 positive\*\*\*, documentation is required to provide rationale why treatment with tebentafusp is not the ideal firstline treatment approach or of the patient's intolerance to tebentafusp.
• • \*\*\*To be enrolled in the HLA-A\*02:01 positive cohort, HLA status must be documented by test results from a CAP/CLIA-certified laboratory.
• • Measurable disease per RECIST v1.1
• • 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
• 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 Biopsy-eligible patients
• • Accessible lesion(s) that permit a total of at least two biopsies without unacceptable risk of a significant procedural complication.
• Exclusion Criteria:
• • Previous treatment with a PKC inhibitor
• • Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors
• • Known symptomatic brain metastases
• • Adverse events from prior anti-cancer therapy that have not resolved
• • Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus
• • Active infection requiring ongoing therapy
• • Recent surgery or radiotherapy
• • Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect
• • Females who are pregnant or breastfeeding
• • Impaired cardiac function
• • Treatment with prohibited medications that cannot be discontinued prior to study entry
• • For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin
• Crizotinib Combination Additional Exclusion Criteria:
• • Prior therapy directly targeting ALK, MET, or ROS1
• • Spinal cord compression
• • History of pneumonitis or interstitial lung disease
• • History of syncope
• • History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment
• PK Substudy (optional) with Pravastatin Additional Exclusion Criteria:
• • Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollment in the study and cannot refrain from them through C2D1
• • Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin
• • Any contraindication associated to the use of statins or hypersensitivity component of pravastatin
• • Active liver disease