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

Active Not RecruitingPhase 1

Sponsor: IDEAYA Biosciences

Conditions: Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Prostate Cancer, Endometrial Cancer

Interventions: IDE-161, Pembrolizumab

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Adult participants must be 18 years of age or older
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:

1. Known primary CNS malignancy
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

Locations (27)

Phoenix, Arizona, United States
Los Angeles, California, United States
Newport Beach, California, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Peoria, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Irving, Texas, United States
San Antonio, Texas, United States
West Valley City, Utah, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States