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

Running, not enrolling · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Prostate Cancer, Endometrial Cancer, Colorectal Cancer, Head and Neck Cancers, Extensive Stage Small Cell Lung Cancer (ES-SCLC), NSCLC

In brief

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

Key facts

Study ID

NCT05787587

Run by

IDEAYA Biosciences

People needed

216

Starts

2023-04-18

Expected to finish

2027-05-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• For Module 2 only, History or allogeneic tissue/solid organ transplant
• For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years
• For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Where it is running

• 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

Full record on ClinicalTrials.gov

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