A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

Last updated: March 31, 2025
Sponsor: IDEAYA Biosciences
Overall Status: Active - Recruiting

Phase

1

Condition

Breast Cancer

Prostate Cancer

Colorectal Cancer

Treatment

IDE-161

Pembrolizumab

Clinical Study ID

NCT05787587
IDE161-001
KEYNOTE-F86
MK-3475-F86
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult participants must be 18 years of age or older

  2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS)tumors

  3. For Module 1 only, Have documented evidence of BRCA1/2 and/or genetic alterationsconferring homologous recombination deficiency (HRD) (ATM, BARD1, BRIP1, CDK12,CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L, NBN, FANCA) For Module 2 only, results of MSI and/or MMR testing required. For Module 2 only, results of BRCA1/2 and HRD gene testing required.

  4. Participant must have progressed on at least one prior line of therapy in theadvanced or metastatic setting that is considered an appropriate standard of care,or for which the participant has documented intolerance

  5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcomais excluded)

  6. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonalantibody (MAB)

Exclusion

Exclusion Criteria:

  1. Known primary CNS malignancy

  2. Impairment of GI function or GI disease that may significantly alter the absorptionof IDE161

  3. Have active, uncontrolled infection

  4. Clinically significant cardiac abnormalities

  5. Major surgery within 4 weeks prior to enrollment

  6. Radiation therapy within 2 weeks prior to enrollment

  7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment

  8. Radioimmunotherapy within 6 weeks of enrollment

  9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment

  10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks,whichever is shorter

  11. Have current active liver or biliary disease

  12. For Module 2 only, History or allogeneic tissue/solid organ transplant

  13. For Module 2 only, Active autoimmune disease that has required systemic treatment inpast 2 years

  14. For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung diseasethat required steroids or has current pneumonitis/interstitial lung disease

Study Design

Total Participants: 216
Treatment Group(s): 2
Primary Treatment: IDE-161
Phase: 1
Study Start date:
April 05, 2023
Estimated Completion Date:
May 31, 2027

Study Description

The purpose of this study is to characterize the safety, tolerability including determination of maximum tolerated dose (MTD), maximum accepted dose (MAD), recommended dose(s) for expansion (RDE) and/or recommended Phase 2 dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of IDE161 as a single agent in participants with advanced or metastatic solid tumors harboring BRCA1/2 loss of function alterations and/or other defects in the homologous recombination (HR) pathway and in combination with pembrolizumab in participants with advanced/recurrent endometrial cancer.

Connect with a study center

  • HonorHealth Research Institute

    Phoenix, Arizona 85027
    United States

    Active - Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona 85719
    United States

    Site Not Available

  • The Angeles Clinic

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Hoag Memorial Hospital

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • California Pacific Medical Center

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Orlando Health

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • OSF St Francis Medical Center

    Peoria, Illinois 61637
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Dana Faber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Weil Cornell University

    New York, New York 10065
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Sarah Cannon Research Institute - Oklahoma University

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Sarah Cannon Research Institute - Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • MD Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Oncology

    Irving, Texas 75039
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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