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Active, not recruiting Phase 1

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

NCT05787587 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2023-04-18
Last updated
2026-07-13

Condition(s) studied

Advanced or Metastatic Solid TumorsBreast CancerOvarian CancerProstate CancerEndometrial CancerColorectal CancerHead and Neck CancersExtensive Stage Small Cell Lung Cancer (ES-SCLC)NSCLC

Investigational drug(s) / intervention(s)

IDE-161Pembrolizumab →

IDE-161: Oral Medication

Pembrolizumab: Intravenous Infusion

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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
    * Incidence of Dose Limiting Toxicities * Incidence of treatment-emergent Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
  • 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
    * Incidence of treatment-emergent AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy * Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing
  • Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab — Approximately 4 years
    Tumor response: Overall Response Rate assessed using RECIST criteria v1.1

Trial sites (27)

FacilityCityRegionStatus
HonorHealth Research Institute Phoenix Arizona
The Angeles Clinic Los Angeles California
Hoag Memorial Hospital Newport Beach California
California Pacific Medical Center San Francisco California
Sarah Cannon Research Institute Denver Colorado
Yale University New Haven Connecticut
Orlando Health Orlando Florida
Emory University Atlanta Georgia
OSF St Francis Medical Center Peoria Illinois
Indiana University Indianapolis Indiana
Dana Faber Cancer Institute Boston Massachusetts
Karmanos Cancer Institute Detroit Michigan
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
Roswell Park Comprehensive Cancer Center Buffalo New York
Columbia University Medical Center New York New York
Weil Cornell University New York New York
Sarah Cannon Research Institute - Oklahoma University Oklahoma City Oklahoma
University of Pennsylvania Philadelphia Pennsylvania
Sarah Cannon Research Institute - Thomas Jefferson University Philadelphia Pennsylvania
Sarah Cannon Research Institute Nashville Tennessee
MD Anderson Houston Texas
NEXT Oncology Irving Texas
NEXT Oncology San Antonio Texas
START Mountain Region West Valley City Utah
NEXT Oncology Fairfax Virginia
Swedish Cancer Institute Seattle Washington
University of Wisconsin Madison Wisconsin
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05787587 on ClinicalTrials.gov ↗ ← All trials in the USA