Clinical Trials in the USA / NCT05787587
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
On this site
📄 Keytruda (pembrolizumab) drug profile →More IDEAYA Biosciences trials in the USA
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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