Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05787587

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

Led by IDEAYA Biosciences · Updated on 2026-02-09

216

Participants Needed

27

Research Sites

210 weeks

Total Duration

On this page

Sponsors

I

IDEAYA Biosciences

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older
  • Have advanced or metastatic solid tumors excluding primary central nervous system tumors
  • For Module 1, documented BRCA1/2 and/or genetic alterations causing homologous recombination deficiency
  • For Module 2, results of MSI and/or MMR testing required
  • For Module 2, results of BRCA1/2 and homologous recombination deficiency gene testing required
  • Have progressed on at least one prior appropriate therapy for advanced or metastatic disease, or have documented intolerance
  • For Module 2, have advanced or metastatic endometrial cancer (excluding uterine carcinosarcoma)
  • For Module 2, have progressed after treatment with an anti-PD-1 or PD-L1 monoclonal antibody
Not Eligible

You will not qualify if you...

  • Known primary central nervous system malignancy
  • Gastrointestinal dysfunction or disease that could affect absorption of IDE161
  • Active, uncontrolled infection
  • Significant cardiac abnormalities
  • Major surgery within 4 weeks before enrollment
  • Radiation therapy within 2 weeks before enrollment
  • Systemic cytotoxic chemotherapy within 4 weeks before enrollment
  • Radioimmunotherapy within 6 weeks before enrollment
  • Treatment with therapeutic antibody within 4 weeks before enrollment
  • Treatment with anti-cancer small molecule within 5 half-lives or 2 weeks, whichever is shorter
  • Active liver or biliary disease
  • For Module 2, history of allogeneic tissue or solid organ transplant
  • For Module 2, active autoimmune disease requiring systemic treatment in past 2 years
  • For Module 2, history or current pneumonitis or interstitial lung disease requiring steroids or ongoing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

HonorHealth Research Institute

Phoenix, Arizona, United States, 85027

Withdrawn

2

The Angeles Clinic

Los Angeles, California, United States, 90025

Actively Recruiting

3

Hoag Memorial Hospital

Newport Beach, California, United States, 92663

Active, Not Recruiting

4

California Pacific Medical Center

San Francisco, California, United States, 94115

Withdrawn

5

Sarah Cannon Research Institute

Denver, Colorado, United States, 80218

Actively Recruiting

6

Yale University

New Haven, Connecticut, United States, 06511

Actively Recruiting

7

Orlando Health

Orlando, Florida, United States, 32806

Withdrawn

8

Emory University

Atlanta, Georgia, United States, 30322

Active, Not Recruiting

9

OSF St Francis Medical Center

Peoria, Illinois, United States, 61637

Withdrawn

10

Indiana University

Indianapolis, Indiana, United States, 46202

Completed

11

Dana Faber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

12

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

13

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

Active, Not Recruiting

14

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14203

Completed

15

Columbia University Medical Center

New York, New York, United States, 10032

Completed

16

Weil Cornell University

New York, New York, United States, 10065

Actively Recruiting

17

Sarah Cannon Research Institute - Oklahoma University

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

18

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Active, Not Recruiting

19

Sarah Cannon Research Institute - Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

20

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

21

MD Anderson

Houston, Texas, United States, 77030

Actively Recruiting

22

NEXT Oncology

Irving, Texas, United States, 75039

Actively Recruiting

23

NEXT Oncology

San Antonio, Texas, United States, 78229

Actively Recruiting

24

START Mountain Region

West Valley City, Utah, United States, 84119

Actively Recruiting

25

NEXT Oncology

Fairfax, Virginia, United States, 22031

Actively Recruiting

26

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Actively Recruiting

27

University of Wisconsin

Madison, Wisconsin, United States, 53792

Actively Recruiting

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Research Team

I

IDEAYA Clinical Trials

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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