Who is eligible for clinical trial NCT05787587?

Participants must meet protocol criteria for Advanced or Metastatic Solid Tumors. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05787587 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-09

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors (NCT05787587)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: IDEAYA Biosciences

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (15 items).

Location: HonorHealth Research Institute — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Adult participants must be 18 years of age or older
Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
For Module 1 only, Have documented evidence of BRCA1/2 and/or genetic alterations conferring 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.
Participant must have progressed on at least one prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care, or for which the participant has documented intolerance
For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Known primary CNS malignancy
Impairment of GI function or GI disease that may significantly alter the absorption of IDE161
Have active, uncontrolled infection
Clinically significant cardiac abnormalities
Major surgery within 4 weeks prior to enrollment
Radiation therapy within 2 weeks prior to enrollment
Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
Radioimmunotherapy within 6 weeks of enrollment
Treatment with a therapeutic antibody within 4 weeks prior to enrollment
Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter
Have current active liver or biliary disease

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (27 Sites)

HonorHealth Research Institute — Phoenix, Arizona
The Angeles Clinic — Los Angeles, California
Hoag Memorial Hospital — Newport Beach, California
California Pacific Medical Center — San Francisco, California
Sarah Cannon Research Institute — Denver, Colorado
Yale University — New Haven, Connecticut
Orlando Health — Orlando, Florida
Emory University — Atlanta, Georgia
OSF St Francis Medical Center — Peoria, Illinois
Indiana University — Indianapolis, Indiana
Dana Faber Cancer Institute — Boston, Massachusetts
Karmanos Cancer Institute — Detroit, Michigan
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada
Roswell Park Comprehensive Cancer Center — Buffalo, New York
Columbia University Medical Center — New York, New York
Weil Cornell University — New York, New York
Sarah Cannon Research Institute - Oklahoma University — Oklahoma City, Oklahoma
University of Pennsylvania — Philadelphia, Pennsylvania
Sarah Cannon Research Institute - Thomas Jefferson University — Philadelphia, Pennsylvania
Sarah Cannon Research Institute — Nashville, Tennessee
MD Anderson — Houston, Texas
NEXT Oncology — Irving, Texas
NEXT Oncology — San Antonio, Texas
START Mountain Region — West Valley City, Utah
NEXT Oncology — Fairfax, Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗