[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05787587":3,"trial-entities:NCT05787587":343,"trial-summary:NCT05787587":359},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":27,"study_type":72,"primary_purpose":73,"phases":74,"enrollment_info":76,"interventions":79,"primary_outcomes":94,"secondary_outcomes":106,"sex":124,"minimum_age":125,"maximum_age":126,"healthy_volunteers":127,"eligibility_criteria":128,"std_ages":132,"locations":135,"central_contacts":336,"overall_officials":337,"references":341,"see_also_links":342},"NCT05787587","IDE161-001","A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors","ACTIVE_NOT_RECRUITING","2027-05","2026-07","2026-07-13","2023-04-18","IDEAYA Biosciences","INDUSTRY",true,"The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.","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\u002For 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\u002F2 loss of function alterations and\u002For other defects in the homologous recombination (HR) pathway and in combination with pembrolizumab in participants with advanced\u002Frecurrent endometrial cancer.",[18,19,20,21,22,23,24,25,26],"Advanced or Metastatic Solid Tumors","Breast Cancer","Ovarian Cancer","Prostate Cancer","Endometrial Cancer","Colorectal Cancer","Head and Neck Cancers","Extensive Stage Small Cell Lung Cancer (ES-SCLC)","NSCLC",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"PARPi","PARP inhibitor","BRCA","HRD gene alteration","Breast","Ovarian","Advanced solid tumors","Metastatic solid tumors","BRCA 1","BRCA 2","Homologous recombination","PARG","PARG Inhibition","ATM","BARD1","BRIP1","CDK12","CHEK1","CHEK2","FANCL","PALB2","PPP2R2A","RAD51C","RAD51D","RAD54L","NBN","FANCA","HRD+","Endometrial","Pembro","Pembrolizumab","HR genes","genomic instability score","GIS","GI+","gLOH","genomic loss of heterozygosity","MSS","MSI","MMR","PD-L1","ES-SCLC","SCLC","Extensive Stage Small Cell Lung Cancer","INTERVENTIONAL","TREATMENT",[75],"PHASE1",{"count":77,"type":78},216,"ESTIMATED",[80,89],{"type":81,"name":82,"description":83,"armGroupLabels":84},"DRUG","IDE-161","Oral Medication",[85,86,87,88],"Module 1 Part 1: Monotherapy Dose Escalation","Module 1 Part 2: Monotherapy Dose Expansion","Module 2 Part 1: Combination Dose Escalation with pembrolizumab","Module 2 Part 2: Combination Dose Expansion with pembrolizumab",{"type":81,"name":58,"description":90,"armGroupLabels":91,"otherNames":92},"Intravenous Infusion",[87,88],[93],"KEYTRUDA®",[95,99,103],{"measure":96,"description":97,"timeFrame":98},"Part 1 (Dose Escalation): To characterize the safety and tolerability of IDE161 monotherapy or in combination with pembrolizumab to determine the MTD and\u002For RDE","* Incidence of Dose Limiting Toxicities\n* 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\n* Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing","Approximately 2 years",{"measure":100,"description":101,"timeFrame":102},"Part 2 (Dose Expansion): To further assess the safety and tolerability of IDE monotherapy and in combination with pembrolizumab at the RDE","* 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\n* Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing","Approximately 4 years",{"measure":104,"description":105,"timeFrame":102},"Part 2 (Dose Expansion): To evaluate preliminary anti-tumor activity of IDE161 monotherapy or in combination with pembrolizumab","Tumor response: Overall Response Rate assessed using RECIST criteria v1.1",[107,110,113,116,118,120,122],{"measure":108,"description":109,"timeFrame":102},"Part 2 (Dose Expansion) Assess the risk\u002Fbenefit 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","Descriptively compare the totality of emerging data (efficacy, safety, PK, PD) between the initial expansion dose cohort and dose optimization cohort",{"measure":111,"description":112,"timeFrame":102},"To characterize the single dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.","Single-dose PK parameters of IDE161",{"measure":114,"description":115,"timeFrame":102},"To characterize the multiple dose PK Peak Plasma Concentration (Cmax) of IDE161 monotherapy and in combination with pembrolizumab.","Multiple-dose PK parameters of IDE161",{"measure":117,"description":112,"timeFrame":102},"To characterize the single dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab.",{"measure":119,"description":115,"timeFrame":102},"To characterize the multiple dose PK Area under the plasma concentration versus time curve (AUC) of IDE161 monotherapy and in combination with pembrolizumab.",{"measure":121,"description":112,"timeFrame":102},"To characterize the single dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab.",{"measure":123,"description":115,"timeFrame":102},"To characterize the multiple dose PK Time to Peak drug Concentration (Tmax) of IDE161 monotherapy and in combination with pembrolizumab.","ALL","18 Years",null,false,{"inclusion":129,"exclusion":130,"raw_text":131},[],[],"Inclusion Criteria:\n\n1. Adult participants must be 18 years of age or older\n2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors\n3. For Module 1 only, Have documented evidence of BRCA1\u002F2 and\u002For genetic alterations conferring homologous recombination deficiency (HRD) (ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L, NBN, FANCA)\n\n   For Module 2 only, results of MSI and\u002For MMR testing required.\n\n   For Module 2 only, results of BRCA1\u002F2 and HRD gene testing required.\n4. 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\n5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)\n6. For Module 2 only, Must have progressed on treatment with an anti-PD-1\u002FL1 monoclonal antibody (MAB)\n\nExclusion Criteria:\n\n1. Known primary CNS malignancy\n2. Impairment of GI function or GI disease that may significantly alter the absorption of IDE161\n3. Have active, uncontrolled infection\n4. Clinically significant cardiac abnormalities\n5. Major surgery within 4 weeks prior to enrollment\n6. Radiation therapy within 2 weeks prior to enrollment\n7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment\n8. Radioimmunotherapy within 6 weeks of enrollment\n9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment\n10. Treatment with an anti-cancer small molecule within 5 half-lives (t1\u002F2), or 2 weeks, whichever is shorter\n11. Have current active liver or biliary disease\n12. For Module 2 only, History or allogeneic tissue\u002Fsolid organ transplant\n13. For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years\n14. For Module 2 only, History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease",[133,134],"ADULT","OLDER_ADULT",[136,145,153,160,167,175,183,191,199,207,215,223,231,239,247,253,257,265,273,277,284,292,299,305,313,320,328],{"facility":137,"city":138,"state":139,"zip":140,"country":141,"geoPoint":142},"HonorHealth Research Institute","Phoenix","Arizona","85027","United States",{"lat":143,"lon":144},33.44838,-112.07404,{"facility":146,"city":147,"state":148,"zip":149,"country":141,"geoPoint":150},"The Angeles Clinic","Los Angeles","California","90025",{"lat":151,"lon":152},34.05223,-118.24368,{"facility":154,"city":155,"state":148,"zip":156,"country":141,"geoPoint":157},"Hoag Memorial Hospital","Newport Beach","92663",{"lat":158,"lon":159},33.61891,-117.92895,{"facility":161,"city":162,"state":148,"zip":163,"country":141,"geoPoint":164},"California Pacific Medical Center","San Francisco","94115",{"lat":165,"lon":166},37.77493,-122.41942,{"facility":168,"city":169,"state":170,"zip":171,"country":141,"geoPoint":172},"Sarah Cannon Research Institute","Denver","Colorado","80218",{"lat":173,"lon":174},39.73915,-104.9847,{"facility":176,"city":177,"state":178,"zip":179,"country":141,"geoPoint":180},"Yale University","New Haven","Connecticut","06511",{"lat":181,"lon":182},41.30815,-72.92816,{"facility":184,"city":185,"state":186,"zip":187,"country":141,"geoPoint":188},"Orlando Health","Orlando","Florida","32806",{"lat":189,"lon":190},28.53834,-81.37924,{"facility":192,"city":193,"state":194,"zip":195,"country":141,"geoPoint":196},"Emory University","Atlanta","Georgia","30322",{"lat":197,"lon":198},33.749,-84.38798,{"facility":200,"city":201,"state":202,"zip":203,"country":141,"geoPoint":204},"OSF St Francis Medical Center","Peoria","Illinois","61637",{"lat":205,"lon":206},40.69365,-89.58899,{"facility":208,"city":209,"state":210,"zip":211,"country":141,"geoPoint":212},"Indiana University","Indianapolis","Indiana","46202",{"lat":213,"lon":214},39.76838,-86.15804,{"facility":216,"city":217,"state":218,"zip":219,"country":141,"geoPoint":220},"Dana Faber Cancer Institute","Boston","Massachusetts","02215",{"lat":221,"lon":222},42.35843,-71.05977,{"facility":224,"city":225,"state":226,"zip":227,"country":141,"geoPoint":228},"Karmanos Cancer Institute","Detroit","Michigan","48201",{"lat":229,"lon":230},42.33143,-83.04575,{"facility":232,"city":233,"state":234,"zip":235,"country":141,"geoPoint":236},"Comprehensive Cancer Centers of Nevada","Las Vegas","Nevada","89169",{"lat":237,"lon":238},36.17497,-115.13722,{"facility":240,"city":241,"state":242,"zip":243,"country":141,"geoPoint":244},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14203",{"lat":245,"lon":246},42.88645,-78.87837,{"facility":248,"city":242,"state":242,"zip":249,"country":141,"geoPoint":250},"Columbia University Medical Center","10032",{"lat":251,"lon":252},40.71427,-74.00597,{"facility":254,"city":242,"state":242,"zip":255,"country":141,"geoPoint":256},"Weil Cornell University","10065",{"lat":251,"lon":252},{"facility":258,"city":259,"state":260,"zip":261,"country":141,"geoPoint":262},"Sarah Cannon Research Institute - Oklahoma University","Oklahoma City","Oklahoma","73104",{"lat":263,"lon":264},35.46756,-97.51643,{"facility":266,"city":267,"state":268,"zip":269,"country":141,"geoPoint":270},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"lat":271,"lon":272},39.95238,-75.16362,{"facility":274,"city":267,"state":268,"zip":275,"country":141,"geoPoint":276},"Sarah Cannon Research Institute - Thomas Jefferson University","19107",{"lat":271,"lon":272},{"facility":168,"city":278,"state":279,"zip":280,"country":141,"geoPoint":281},"Nashville","Tennessee","37203",{"lat":282,"lon":283},36.16589,-86.78444,{"facility":285,"city":286,"state":287,"zip":288,"country":141,"geoPoint":289},"MD Anderson","Houston","Texas","77030",{"lat":290,"lon":291},29.76328,-95.36327,{"facility":293,"city":294,"state":287,"zip":295,"country":141,"geoPoint":296},"NEXT Oncology","Irving","75039",{"lat":297,"lon":298},32.81402,-96.94889,{"facility":293,"city":300,"state":287,"zip":301,"country":141,"geoPoint":302},"San Antonio","78229",{"lat":303,"lon":304},29.42412,-98.49363,{"facility":306,"city":307,"state":308,"zip":309,"country":141,"geoPoint":310},"START Mountain Region","West Valley City","Utah","84119",{"lat":311,"lon":312},40.69161,-112.00105,{"facility":293,"city":314,"state":315,"zip":316,"country":141,"geoPoint":317},"Fairfax","Virginia","22031",{"lat":318,"lon":319},38.84622,-77.30637,{"facility":321,"city":322,"state":323,"zip":324,"country":141,"geoPoint":325},"Swedish Cancer Institute","Seattle","Washington","98104",{"lat":326,"lon":327},47.60621,-122.33207,{"facility":329,"city":330,"state":331,"zip":332,"country":141,"geoPoint":333},"University of Wisconsin","Madison","Wisconsin","53792",{"lat":334,"lon":335},43.07305,-89.40123,[],[338],{"name":339,"affiliation":12,"role":340},"Darrin Beaupre, MD,PhD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":344,"biomarkers":354},[345,346,347,348,349,350,351,352,353],"Breast Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Lung Non-Small Cell Carcinoma","Lung Small Cell Carcinoma","Malignant Head and Neck Neoplasm","Malignant Ovarian Neoplasm","Prostate Carcinoma","Solid Neoplasm",[355,356,357,358],"BRCA Gene Family","MRC1 wt Allele","MSI1 Gene","TBCE wt Allele",{"nct_id":4,"found":127,"summary":126,"prompt_version":126}]