> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-parg-inhibitor-ide161-in-participants-with-70e76ae4-5035-4e77-9841-1a868aeab91d > Record changed: 2026-10-13 # A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors NCT05787587 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) Participants 216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) Lead sponsor IDEAYA Biosciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) Start date 2023-04-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) Number of sites 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Short title** A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Official title** A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Dates **Completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **First posted** 2023-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Registry last updated** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Primary completion date** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Start date** 2023-04-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Size and sites **Participants** 216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Planned participants** 216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Number of sites** 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Lead sponsor** IDEAYA Biosciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Identifiers **Registry ID** NCT05787587 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **ClinicalTrials.gov ID** NCT05787587 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Outcomes ### Primary outcomes 1. 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 Timeframe: 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 2. Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE Timeframe: 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 3. Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab Timeframe: Approximately 4 years Tumor response: Overall Response Rate assessed using RECIST criteria v1.1 ### Secondary outcomes 1. Part 2 (Dose Expansion) Assess the risk/benefit at an IDE161 monotherapy dose and exposure alternative to the initial expansion dose; as well as an IDE161 dose in combination with a fixed dose of pembrolizumab and exposure alternative to the initial Timeframe: Approximately 4 years Descriptively compare the totality of emerging data (efficacy, safety, PK, PD) between the initial expansion dose cohort and dose optimization cohort 2. To characterize the single dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab. Timeframe: Approximately 4 years Single-dose PK parameters of IDE161 3. To characterize the multiple dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab. Timeframe: Approximately 4 years Multiple-dose PK parameters of IDE161 4. To characterize the single dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab. Timeframe: Approximately 4 years Single-dose PK parameters of IDE161 5. To characterize the multiple dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab. Timeframe: Approximately 4 years Multiple-dose PK parameters of IDE161 6. To characterize the single dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab. Timeframe: Approximately 4 years Single-dose PK parameters of IDE161 7. To characterize the multiple dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab. Timeframe: Approximately 4 years Multiple-dose PK parameters of IDE161 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Sites - HonorHealth Research InstitutePhoenix, United States - The Angeles ClinicLos Angeles, United States - Hoag Memorial HospitalNewport Beach, United States - California Pacific Medical CenterSan Francisco, United States - Sarah Cannon Research InstituteDenver, United States - Yale UniversityNew Haven, United States - Orlando HealthOrlando, United States - Emory UniversityAtlanta, United States - OSF St Francis Medical CenterPeoria, United States - Indiana UniversityIndianapolis, United States - Dana Faber Cancer InstituteBoston, United States - Karmanos Cancer InstituteDetroit, United States - Comprehensive Cancer Centers of NevadaLas Vegas, United States - Roswell Park Comprehensive Cancer CenterBuffalo, United States - Columbia University Medical CenterNew York, United States - Weil Cornell UniversityNew York, United States - Sarah Cannon Research Institute - Oklahoma UniversityOklahoma City, United States - University of PennsylvaniaPhiladelphia, United States - Sarah Cannon Research Institute - Thomas Jefferson UniversityPhiladelphia, United States - Sarah Cannon Research InstituteNashville, United States - MD AndersonHouston, United States - NEXT OncologyIrving, United States - NEXT OncologySan Antonio, United States - START Mountain RegionWest Valley City, United States - NEXT OncologyFairfax, United States And 2 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## References ### Other registry identifiers - KEYNOTE-F86 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787587) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [IDEAYA Biosciences](https://trialight.com/data/company/ideaya-biosciences-6565808c-7b48-4979-837b-2f3b3a0b6465.md) ### Conditions (12) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Head and neck cancer](https://trialight.com/data/condition/head-and-neck-cancer-3a2645b9-a3db-5103-b6f8-5d2ec40c5339.md) - [Head and neck neoplasm](https://trialight.com/data/condition/head-and-neck-neoplasm-6436d68c-825f-5a7a-bb29-99e9ae9e009a.md) - [Intellectual disability, X-linked, with or without seizures, ARX-related](https://trialight.com/data/condition/intellectual-disability-x-linked-with-or-without-seizures-87c36cc1-14c9-5d52-9828-8aa75972ce36.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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