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

Part of paid clinical trials in Los Angeles, California.

Sponsor
IDEAYA Biosciences
Study ID
NCT03947385
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IDE196 — DRUG
    IDE196 dosed orally, twice daily for each 28-day cycle
  • Binimetinib — DRUG
    Binimetinib dosed orally, twice daily for each 28-day cycle
  • Crizotinib — DRUG
    Crizotinib dosed orally, twice daily for each 28-day cycle

Study Details

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 (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.

Key Dates

Start date
Jun 28, 2019
Status verified
Jun 2026
Primary completion
Jan 29, 2027
Completion
Jun 15, 2027

Study Design

Enrollment
336 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Monotherapy (Enrollment Complete)
    IDE196 dosed orally, twice daily (BID) for each 28-day cycle
  • Experimental: Dose Expansion Monotherapy (Enrollment Complete)
    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 (Enrollment Complete)
    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 (Enrollment Complete)
    RP2D in MUM and non-MUM tumors harboring GNAQ/11 mutations (cutaneous melanoma, CRC, other solid tumors)
  • Experimental: Dose Escalation Crizotinib Combination (Enrollment Complete)
    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 (Enrolling)
    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.
  • Experimental: Dose Optimization Crizotinib Combination (Enrollment Complete)
    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 (Enrollment Complete)
    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

Primary Outcome Measure

Dose-limiting Toxicity (DLT) [ Time Frame: 28 days following first dose of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095
Bartosz Chmielowski, MD
[email protected]
Bartosz Chmielowski, MD (PRINCIPAL_INVESTIGATOR)
San Francisco Oncology AssociatesSan FranciscoCalifornia94115-
SCRI - DenverDenverColorado80218
Ryan Weight, MD
[email protected]
Ryan Weight, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242-
Cancer Hematology Centers Western MichiganGrand RapidsMichigan49503-
Columbia University Medical Center - Herbert Irving PavilionNew YorkNew York10032-
Duke University Medical CenterDurhamNorth Carolina27710
Carol A Wiggs
[email protected]
April Salama, MD (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer CenterCincinnatiOhio45267
513-584-7698
Trisha Wise-Draper, MD (PRINCIPAL_INVESTIGATOR)
The Cleveland Clinic FoundationClevelandOhio44195-
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Marlana Orloff, MD
[email protected]
Marlana Orloff, MD (PRINCIPAL_INVESTIGATOR)
The Sarah Cannon Research Institute/Tennessee OncologyNashvilleTennessee37203
askSARAH
844-482-4812
Meredith McKean, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Jordi Ahnert, MD
[email protected]
Jordi Rodon Ahnert, MD (PRINCIPAL_INVESTIGATOR)

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