A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
NCT ID: NCT05787587
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
216 participants
INTERVENTIONAL
2023-04-18
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Module 2 Part 2: Combination Dose Expansion with pembrolizumab
After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
IDE-161
Oral Medication
Pembrolizumab
Intravenous Infusion
Module 1 Part 1: Monotherapy Dose Escalation
Participants will be assigned to a dose level.
IDE-161
Oral Medication
Module 1 Part 2: Monotherapy Dose Expansion
After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.
IDE-161
Oral Medication
Module 2 Part 1: Combination Dose Escalation with pembrolizumab
Participants will be assigned to a dose level.
IDE-161
Oral Medication
Pembrolizumab
Intravenous Infusion
Interventions
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IDE-161
Oral Medication
Pembrolizumab
Intravenous Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
4. 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
5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
6. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)
Exclusion Criteria
2. Impairment of GI function or GI disease that may significantly alter the absorption of 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 in past 2 years
14. For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
IDEAYA Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Darrin Beaupre, MD,PhD
Role: STUDY_DIRECTOR
IDEAYA Biosciences
Locations
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HonorHealth Research Institute
Phoenix, Arizona, United States
The Angeles Clinic
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
California Pacific Medical Center
San Francisco, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
Orlando Health
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
OSF St Francis Medical Center
Peoria, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
Weil Cornell University
New York, New York, United States
Sarah Cannon Research Institute - Oklahoma University
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute - Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
NEXT Oncology
Irving, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
NEXT Oncology
Fairfax, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials
Role: primary
Other Identifiers
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KEYNOTE-F86
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-F86
Identifier Type: OTHER
Identifier Source: secondary_id
IDE161-001
Identifier Type: -
Identifier Source: org_study_id
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