TrialPath
← Back to searchRecruiting

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

NCT05787587 · IDEAYA Biosciences
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
The purpose of this study is to characterize the safety, tolerability including determination of maximum tolerated dose (MTD), maximum accepted dose (MAD), recommended dose(s) for expansion (RDE) and/or recommended Phase 2 dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of IDE161 as a single agent in participants with advanced or metastatic solid tumors harboring BRCA1/2 loss of function alterations and/or other defects in the homologous recombination (HR) pathway and in combination with pembrolizumab in participants with advanced/recurrent endometrial cancer.
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
Study design
Enrollment target: 216 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-04-18
Estimated completion: 2027-05
Last updated: 2026-02-09
Interventions
Drug: IDE-161Drug: Pembrolizumab
Primary outcomes
  • Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and/or RDE (Approximately 2 years)
  • Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE (Approximately 4 years)
  • Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab (Approximately 4 years)
Sponsor
IDEAYA Biosciences · industry
With: Merck Sharp & Dohme LLC
Contacts & investigators
ContactIDEAYA Clinical Trials · contact · IDEAYAClinicalTrials@ideayabio.com · 855-IDEA-BIO (855-433-2246)
InvestigatorDarrin Beaupre, MD,PhD · study_director, IDEAYA Biosciences
All locations (27)
HonorHealth Research InstituteWithdrawn
Phoenix, Arizona, United States
The Angeles ClinicRecruiting
Los Angeles, California, United States
Hoag Memorial HospitalActive Not Recruiting
Newport Beach, California, United States
California Pacific Medical CenterWithdrawn
San Francisco, California, United States
Sarah Cannon Research InstituteRecruiting
Denver, Colorado, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Orlando HealthWithdrawn
Orlando, Florida, United States
Emory UniversityActive Not Recruiting
Atlanta, Georgia, United States
OSF St Francis Medical CenterWithdrawn
Peoria, Illinois, United States
Indiana UniversityCompleted
Indianapolis, Indiana, United States
Dana Faber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Comprehensive Cancer Centers of NevadaActive Not Recruiting
Las Vegas, Nevada, United States
Roswell Park Comprehensive Cancer CenterCompleted
Buffalo, New York, United States
Columbia University Medical CenterCompleted
New York, New York, United States
Weil Cornell UniversityRecruiting
New York, New York, United States
Sarah Cannon Research Institute - Oklahoma UniversityRecruiting
Oklahoma City, Oklahoma, United States
University of PennsylvaniaActive Not Recruiting
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute - Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
MD AndersonRecruiting
Houston, Texas, United States
NEXT OncologyRecruiting
Irving, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
START Mountain RegionRecruiting
West Valley City, Utah, United States
NEXT OncologyRecruiting
Fairfax, Virginia, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors · TrialPath