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

Study 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

  • - 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. 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 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:

  • - Known symptomatic brain metastases.
  • - 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.
  • - 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.
Binimetinib Combination Additional Exclusion Criteria.
  • - Prior treatment with a MEK inhibitor.
  • - History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
  • - History of interstitial lung disease.
  • - History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to first dose.
  • - Concurrent neuromuscular disorders that are associated with elevated creatine phosphokinase (CPK) - Uncontrolled arterial hypertension despite medical treatment.
  • - Allergy to binimetinib or its components.
  • - History of syncope.
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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03947385
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 IDEAYA Biosciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jasgit Sachdev, MD
Principal Investigator Affiliation jsachdev@ideayabio.com
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Australia, Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer, Other Solid Tumors
Arms & Interventions

Arms

Experimental: Dose Escalation Monotherapy

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

Experimental: Dose Expansion Monotherapy

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

Experimental: Dose Escalation Binimetinib Combination

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

Experimental: Dose Expansion Binimetinib Combination

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

Experimental: Dose Escalation Crizotinib Combination

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

Experimental: Dose Expansion Crizotinib Combination

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

Experimental: Dose Optimization Crizotinib Combination

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

Experimental: Crizotinib Monotherapy with Crossover to Combination

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

Experimental: Tablet PK Substudy

IDE196 dosed orally, once on Cycle 1 Day 1; thereafter, twice daily (BID) for each 28-day cycle

Interventions

Drug: - IDE196

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

Drug: - Binimetinib

Binimetinib dosed orally, twice daily for each 28-day cycle

Drug: - Crizotinib

Crizotinib dosed orally, twice daily for each 28-day cycle

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

HonorHealth Research Institute, Scottsdale, Arizona

Status

Completed

Address

HonorHealth Research Institute

Scottsdale, Arizona, 85258

UCLA Medical Center, Los Angeles, California

Status

Recruiting

Address

UCLA Medical Center

Los Angeles, California, 90095

Site Contact

Bartosz Chmielowski, MD

BChmielowski@mednet.ucla.edu

+1 650 534 3616

San Francisco Oncology Associates, San Francisco, California

Status

Recruiting

Address

San Francisco Oncology Associates

San Francisco, California, 94115

Florida Cancer Specialist South, Fort Myers, Florida

Status

Completed

Address

Florida Cancer Specialist South

Fort Myers, Florida, 33901

Florida Cancer Specialist North, Saint Petersburg, Florida

Status

Completed

Address

Florida Cancer Specialist North

Saint Petersburg, Florida, 33705

Mosaic Life Care, Saint Joseph, Missouri

Status

Completed

Address

Mosaic Life Care

Saint Joseph, Missouri, 64507

New York, New York

Status

Recruiting

Address

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032

Site Contact

Shaheer Khan, MD

sk4488@cumc.columbia.edu

+1 650 534 3616

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Carol A Wiggs

cao13@duke.edu

+1 650 534 3616

University of Cincinnati Cancer Center, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45267

Philadelphia, Pennsylvania

Status

Recruiting

Address

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Marlana Orloff, MD

marlana.orloff@jefferson.edu

+1 650 534 3616

Nashville, Tennessee

Status

Recruiting

Address

The Sarah Cannon Research Institute/Tennessee Oncology

Nashville, Tennessee, 37203

Houston, Texas

Status

Recruiting

Address

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Jordi Ahnert, MD

JRodon@mdanderson.org

+1 650 534 3616

International Sites

Westmead Hospital, Sydney, New South Wales, Australia

Status

Recruiting

Address

Westmead Hospital

Sydney, New South Wales,

Site Contact

Matteo Carlino, MD

IDEAYAClinicalTrials@ideayabio.com

+61 288 905 200

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto, Ontario, OPG 7-815

Site Contact

Melissa Da Ponte

Melissa.DaPonte@uhn.ca

416-946-4501 #5485

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