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Taking peoplePhase 1/2

Tests IDE196 alone and with other drugs in solid tumors with GNAQ/11 changes

Tests IDE196, alone or with other drugs, in adults with GNAQ or GNA11 gene changes.

Key facts

Who runs it
IDEAYA Biosciences
Where
Toronto, CanadaSee the siteAlso in 2 other countries, 14 sites
Trial code
Registry title
Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Status
Recruiting
Phase
Phase 1/2
People taking part
336 people, planned
Started
28 Jun 2019
Expected to end
15 Jun 2027
Type of study
Interventional, 8 groups
Treatments tested
  • IDE196
  • Binimetinib
  • Crizotinib
Record updated
8 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a solid tumor, mainly metastatic uveal melanoma, that has spread and can be measured on scans. The study tests IDE196 alone or with binimetinib or crizotinib.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Metastatic uveal melanoma with confirmed spread, or other solid tumors such as cutaneous melanoma or colorectal cancer. The disease must be measurable by RECIST v1.1. Life expectancy must be more than 3 months.
Earlier treatment
Metastatic uveal melanoma may be untreated, or may have grown on or after the most recent therapy. People with an earlier PKC inhibitor cannot join. For the crizotinib combination, earlier chemotherapy or major surgery must have ended at least 4 weeks before starting crizotinib.
Biomarker or test result
The tumor must have GNAQ or GNA11 mutations or PRKC fusions. People in the HLA-A*02:01 positive group need a documented HLA test result from a CAP/CLIA-certified laboratory.

Main reasons for not taking part

  • Earlier treatment with a PKC inhibitor
  • Known symptomatic brain metastases
  • AIDS-related illness, hepatitis B or hepatitis C
  • Pregnancy or breastfeeding
  • Impaired heart function

The registry criteria, word for word

Show all 35 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous treatment with a PKC inhibitor
  • Known MSI-H/dMMR tumors who have not previously received immune checkpoint inhibitors
  • Adverse events from prior anti-cancer therapy that have not resolved
  • Recent surgery or radiotherapy
  • Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect
  • 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
  • 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
  • Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1
  • Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit/grapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1
  • Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1
  • Moderate and strong inhibitors of CYP2A4/5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1
  • Intake of strong or moderate inducers of CYP3A4/5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1
  • Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus
  • Active infection requiring ongoing therapy
  • Impaired cardiac function
  • History of pneumonitis or interstitial lung disease
  • History of syncope
  • Any contraindication associated to the use of statins or hypersensitivity component of pravastatin
  • Active liver disease; DDI Cocktail Substudy Additional Exclusion Criteria:
  • Known symptomatic brain metastases
  • Females who are pregnant or breastfeeding
  • Spinal cord compression

Where in Canada

Also in 2 other countries, 14 sites

  • Princess Margaret Cancer CentreToronto, CanadaContact: IDEAYA Clinical TrialsNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 (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. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study.

Crizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity.

As of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.

The 8 groups in the trial

  • Dose Escalation Monotherapy (Enrollment Complete)Treatment being tested

    IDE196 dosed orally, twice daily (BID) for each 28-day cycle

    Treatment: IDE196

  • Dose Expansion Monotherapy (Enrollment Complete)Treatment being tested

    RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations or PRKC fusions (cutaneous melanoma, CRC, other solid tumors)

    Treatment: IDE196

  • Dose Escalation Binimetinib Combination (Enrollment Complete)Treatment being tested

    IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Binimetinib dosed orally, twice daily (BID) for each 28-day cycle

    Treatment: IDE196 and Binimetinib

  • Dose Expansion Binimetinib Combination (Enrollment Complete)Treatment being tested

    RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations (cutaneous melanoma, CRC, other solid tumors)

    Treatment: IDE196 and Binimetinib

  • Dose Escalation Crizotinib Combination (Enrollment Complete)Treatment being tested

    IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Crizotinib dosed orally, twice daily (BID) for each 28-day cycle

    Treatment: IDE196 and Crizotinib

  • Dose Expansion Crizotinib Combination (Enrolling)Treatment being tested

    MUM patients (previously treated or treatment naive) with human leukocyte antigen (HLA)-A\*02:01 positive status. Includes a nested PK sub-study with Pravastatin (\~22 participants) to evaluate the impact of pravastatin PK profiles after continuous dosing of IDE196. Includes a nested PK Cocktail DDI sub-study (\~15 participants) to evaluate the impact on the PK of bupripion, repaglinide, flurbiprofen, omeprazole, midazolam, dabigatran etexilate, and the exposures of the OAT3 biomarker PDA by IDE196 in combination with crizotinib.

    Treatment: IDE196 and Crizotinib

  • Dose Optimization Crizotinib Combination (Enrollment Complete)Treatment being tested

    IDE196 dosed orally, twice daily (BID) for each 28-day cycle and Crizotinib dosed orally, twice daily (BID) for each 28-day cycle

    Treatment: IDE196 and Crizotinib

  • Crizotinib Monotherapy with Crossover to Combination (Enrollment Complete)Treatment being tested

    Crizotinib dosed orally, twice daily (BID) for each 28-day cycle until disease progression then IDE196 added and dosed orally, twice daily (BID) for each 28-day cycle

    Treatment: IDE196 and Crizotinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Plain-language title
Tests IDE196 alone and with other drugs in solid tumors with GNAQ/11 changesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 June 2026