Actively Recruiting
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
Eligibility Criteria
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
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
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
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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