[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05238922":3,"trial-entities:NCT05238922":490,"trial-summary:NCT05238922":503},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":39,"primary_purpose":40,"phases":41,"enrollment_info":43,"interventions":46,"primary_outcomes":97,"secondary_outcomes":115,"sex":147,"minimum_age":148,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":149,"std_ages":188,"locations":191,"central_contacts":480,"overall_officials":481,"references":485,"see_also_links":486},"NCT05238922","INCB 123667-101","Study of INCB123667 in Subjects With Advanced Solid Tumors","A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors","ACTIVE_NOT_RECRUITING","2027-08-31","2026-07","2026-07-21","2022-07-05","Incyte Corporation","INDUSTRY",false,"This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).",null,[19],"Solid Tumors",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38],"advanced solid tumors","metastatic solid tumors","Gynecological Tumors,","GI Tumors,","Breast Cancer,","Tumor Agnostic","cyclin E1 gene","epithelial ovarian carcinoma","fallopian carcinoma","primary peritoneal carcinoma","clear cell ovarian cancer","endometrial adenocarcinoma","uterine carcinosarcoma","uterine papillary serous carcinoma","gastrointestinal tumors","gastric adenocarcinomas","GEJ adenocarcinomas","esophageal adenocarcinomas","INTERVENTIONAL","TREATMENT",[42],"PHASE1",{"count":44,"type":45},291,"ACTUAL",[47,73,77,81,85,89,93],{"type":48,"name":49,"description":50,"armGroupLabels":51},"DRUG","INCB0123667","25 mg tablets",[52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"Phase 1a Dose Escalation","Phase 1b: Dose Expansion Cohort Disease Group 1","Phase 1b: Dose Expansion Cohort Disease Group 2","Phase 1b: Dose Expansion Cohort Disease Group 3","Phase 1b: Dose Expansion Cohort Disease Group 4","Phase 1b: Dose Expansion Cohort Disease Group 5","Phase 1b: Dose Expansion Cohort Disease Group 6","Phase 2a Dose Escalation Treatment Group A (TGA)","Phase 2a Dose Escalation Treatment Group B (TGB)","Phase 2a Dose Escalation Treatment Group C (TGC)","Phase 2a Dose Escalation Treatment Group D (TGD)","Phase 2a Dose Escalation Treatment Group E (TGE)","Phase 2a Dose Escalation Treatment Group F (TGF)","Phase 2a Dose Escalation Treatment Group G (TGG)","Phase 2b Dose Expansion Treatment Group H (TGH)","Phase 2b Dose Expansion Treatment Group I (TGI)","Phase 2b Dose Expansion Treatment Group J (TGJ)","Phase 2b Dose Expansion Treatment Group K (TGK)","Phase 2b Dose Expansion Treatment Group L (TGL)","Phase 2b Dose Expansion Treatment Group M (TGM)","Phase 2b Dose Expansion Treatment Group N (TGN)",{"type":48,"name":74,"description":75,"armGroupLabels":76},"Palbociclib","Palbociclib will be administered at protocol defined dose.",[59,60,66,67],{"type":48,"name":78,"description":79,"armGroupLabels":80},"Bevacizumab","Bevacizumab will be administered at protocol defined dose.",[63,70],{"type":48,"name":82,"description":83,"armGroupLabels":84},"Olaparib","Olaparib will be administered at protocol defined dose.",[64,71],{"type":48,"name":86,"description":87,"armGroupLabels":88},"Paclitaxel","Paclitaxel will be administered at protocol defined dose.",[65,72],{"type":48,"name":90,"description":91,"armGroupLabels":92},"Ribociclib","Ribociclib will be administered at protocol defined dose.",[61,62,68,69],{"type":48,"name":94,"description":95,"armGroupLabels":96},"Fulvestrant","Fulvestrant will be administered at protocol defined dose.",[60,62,67,69],[98,102,106,109,112],{"measure":99,"description":100,"timeFrame":101},"Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)","Toxicities occurring during the first treatment cycle, Part 1a, will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.","Up to Day 28",{"measure":103,"description":104,"timeFrame":105},"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.","Up to 12 months",{"measure":107,"description":108,"timeFrame":105},"Number of Participants with Dose Interruptions due to TEAE","Participants will receive dose reductions of INCB123667 according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.",{"measure":110,"description":111,"timeFrame":105},"Number of Participants who Undergo Dose Reductions due to TEAE","Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.",{"measure":113,"description":114,"timeFrame":105},"Number of Participants Discontinue study due to TEAE","TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.",[116,120,123,126,129,132,135,138,141,144],{"measure":117,"description":118,"timeFrame":119},"PK parameters: Cmax","Defines as the maximum (peak) plasma drug concentration","Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)",{"measure":121,"description":122,"timeFrame":119},"PK parameters: tmax","Defined as the time to reach maximum (peak) plasma concentration following drug administration",{"measure":124,"description":125,"timeFrame":119},"PK parameters: Ctau","Ctau is defined as concentration at the end of the dosing interval",{"measure":127,"description":128,"timeFrame":119},"PK Parameters: AUC","Defined as the area under the plasma concentration-time curve",{"measure":130,"description":131,"timeFrame":119},"PK Parameters: CL\u002FF","Defined as the apparent total body clearance of the drug from plasma",{"measure":133,"description":134,"timeFrame":119},"PK Parameters: Vz\u002FF","Defined as apparent volume of distribution during terminal phase",{"measure":136,"description":137,"timeFrame":119},"PK Parameters: t1\u002F2","Defined as Elimination half-life (to be used in one-or noncompartmental model)",{"measure":139,"description":140,"timeFrame":105},"Objective Response Rate (ORR)","Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.",{"measure":142,"description":143,"timeFrame":105},"Disease Control","Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.",{"measure":145,"description":146,"timeFrame":105},"Duration of Response (DOR)","Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.","ALL","18 Years",{"inclusion":150,"exclusion":170,"raw_text":187},[151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169],"Adults aged 18 years or older at the time of the signing of the ICF.","Life expectancy greater than 12 weeks.","ECOG performance status score of 0 or 1.","Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.","Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy.","Disease Group 1: Ovarian\u002FFallopian\u002FPrimary Peritoneal Cancer","Disease Group 2: Endometrial\u002FUterine Cancer","Disease Group 3: Gastric, GEJ, and esophageal carcinomas","Disease Group 4: TNBC","Disease Group 5: HR+\u002FHER2- breast cancer","Disease Group 6: Other tumor indications excluding bone cancers","TGA, TGC, TGE, TGF, and TGG: Participants with HR+\u002FHER2- breast cancer or participants with a different tumor.","TGB and TGD: Participants with HR+\u002FHER2- breast cancer.","TGH and TGJ:","Participants with HR+\u002FHER2- breast cancer.","Participants with any other advanced or metastatic solid tumor.","TGI and TGK:","TGL, TGM and TGN:","Measurable lesions by CT or MRI based on RECIST v1.1 criteria.",[171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186],"History of clinically significant or uncontrolled cardiac disease.","History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.","Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.","Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.","Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study drug.","Specific laboratory values.","Significant concurrent, uncontrolled medical conditions, including but not limited to Hepatic and Gastrointestinal.","Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and\u002For complications from prior surgical intervention before starting study drug.","Prior treatment with any CDK2 inhibitor.","Any change in endocrine therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug or any administration of targeted therapy, antibody, or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.","Any major surgery within 28 days before the first dose of study drug.","Any prior radiation therapy within 28 days before the first dose of study drug.","Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.","Active HBV or HCV infection that requires treatment.","Known history of HIV.","Known hypersensitivity or severe reaction to any component of study treatment or formulation components.","Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of the signing of the ICF.\n* Life expectancy greater than 12 weeks.\n* ECOG performance status score of 0 or 1.\n* Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.\n* Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy.\n\nFor Part 1:\n\nParticipants in Part 1A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.\n\nParticipants in Part 1B (dose expansion):\n\n* Disease Group 1: Ovarian\u002FFallopian\u002FPrimary Peritoneal Cancer\n* Disease Group 2: Endometrial\u002FUterine Cancer\n* Disease Group 3: Gastric, GEJ, and esophageal carcinomas\n* Disease Group 4: TNBC\n* Disease Group 5: HR+\u002FHER2- breast cancer\n* Disease Group 6: Other tumor indications excluding bone cancers\n\nFor Part 2:\n\nParticipants in Part 2A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.\n\n* TGA, TGC, TGE, TGF, and TGG: Participants with HR+\u002FHER2- breast cancer or participants with a different tumor.\n* TGB and TGD: Participants with HR+\u002FHER2- breast cancer.\n\nParticipants in Part 2b (dose expansion):\n\n* TGH and TGJ:\n\n  * Participants with HR+\u002FHER2- breast cancer.\n  * Participants with any other advanced or metastatic solid tumor.\n* TGI and TGK:\n\n  • Participants with HR+\u002FHER2- breast cancer.\n* TGL, TGM and TGN:\n\n  • Participants with advanced or metastatic epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma.\n* Measurable lesions by CT or MRI based on RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n* History of clinically significant or uncontrolled cardiac disease.\n* History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.\n* Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.\n* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.\n* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study drug.\n* Specific laboratory values.\n* Significant concurrent, uncontrolled medical conditions, including but not limited to Hepatic and Gastrointestinal.\n* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and\u002For complications from prior surgical intervention before starting study drug.\n* Prior treatment with any CDK2 inhibitor.\n* Any change in endocrine therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug or any administration of targeted therapy, antibody, or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.\n* Any major surgery within 28 days before the first dose of study drug.\n* Any prior radiation therapy within 28 days before the first dose of study drug.\n* Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.\n* Active HBV or HCV infection that requires treatment.\n* Known history of HIV.\n* Known hypersensitivity or severe reaction to any component of study treatment or formulation components.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",[189,190],"ADULT","OLDER_ADULT",[192,201,208,215,223,231,239,247,254,258,265,273,281,288,292,300,308,316,324,332,339,346,353,361,368,375,382,389,397,401,405,412,416,424,431,439,447,454,461,469,473],{"facility":193,"city":194,"state":195,"zip":196,"country":197,"geoPoint":198},"City of Hope Medical Center","Duarte","California","91010","United States",{"lat":199,"lon":200},34.13945,-117.97729,{"facility":202,"city":203,"state":195,"zip":204,"country":197,"geoPoint":205},"City of Hope-Lennar Foundation Cancer Center","Irvine","92618",{"lat":206,"lon":207},33.66946,-117.82311,{"facility":209,"city":210,"state":195,"zip":211,"country":197,"geoPoint":212},"Valkyrie Clinical Trials","Los Angeles","90067",{"lat":213,"lon":214},34.05223,-118.24368,{"facility":216,"city":217,"state":218,"zip":219,"country":197,"geoPoint":220},"Rocky Mountain Cancer Centers-Sky Ridge","Lone Tree","Colorado","80124",{"lat":221,"lon":222},39.55171,-104.8863,{"facility":224,"city":225,"state":226,"zip":227,"country":197,"geoPoint":228},"Yale Cancer Center","New Haven","Connecticut","06510",{"lat":229,"lon":230},41.30815,-72.92816,{"facility":232,"city":233,"state":234,"zip":235,"country":197,"geoPoint":236},"Mount Sinai Medical Center Comprehensive Cancer Center","Miami Beach","Florida","33140",{"lat":237,"lon":238},25.79065,-80.13005,{"facility":240,"city":241,"state":242,"zip":243,"country":197,"geoPoint":244},"Emory University","Atlanta","Georgia","30322",{"lat":245,"lon":246},33.749,-84.38798,{"facility":248,"city":249,"state":249,"zip":250,"country":197,"geoPoint":251},"Memorial Sloan Kettering Cancer Center","New York","10022",{"lat":252,"lon":253},40.71427,-74.00597,{"facility":255,"city":249,"state":249,"zip":256,"country":197,"geoPoint":257},"New York Presbyterian\u002FWeill Cornell","10065",{"lat":252,"lon":253},{"facility":259,"city":260,"state":249,"zip":261,"country":197,"geoPoint":262},"Ny Cancer and Blood Specialists","Shirley","11967",{"lat":263,"lon":264},40.80149,-72.8676,{"facility":266,"city":267,"state":268,"zip":269,"country":197,"geoPoint":270},"Carolina Bio-Oncology Institute, Pllc","Huntersville","North Carolina","28078",{"lat":271,"lon":272},35.41069,-80.84285,{"facility":274,"city":275,"state":276,"zip":277,"country":197,"geoPoint":278},"University of Pennsylvania Abramson Cancer Center","Philadelphia","Pennsylvania","19104",{"lat":279,"lon":280},39.95238,-75.16362,{"facility":282,"city":283,"state":276,"zip":284,"country":197,"geoPoint":285},"University of Pittsburgh Cancer Institute Cancer Services","Pittsburgh","15213",{"lat":286,"lon":287},40.44062,-79.99589,{"facility":289,"city":283,"state":276,"zip":290,"country":197,"geoPoint":291},"Allegheny Health Network","15224",{"lat":286,"lon":287},{"facility":293,"city":294,"state":295,"zip":296,"country":197,"geoPoint":297},"Tennessee Oncology","Nashville","Tennessee","37203",{"lat":298,"lon":299},36.16589,-86.78444,{"facility":301,"city":302,"state":303,"zip":304,"country":197,"geoPoint":305},"Texas Oncology-Fort Worth South Henderson","Fort Worth","Texas","76104",{"lat":306,"lon":307},32.72541,-97.32085,{"facility":309,"city":310,"state":311,"zip":312,"country":197,"geoPoint":313},"Virginia Cancer Institute","Fairfax","Virginia","22031",{"lat":314,"lon":315},38.84622,-77.30637,{"facility":317,"city":318,"state":319,"zip":320,"country":197,"geoPoint":321},"University of Wisconsin","Madison","Wisconsin","53792",{"lat":322,"lon":323},43.07305,-89.40123,{"facility":325,"city":326,"zip":327,"country":328,"geoPoint":329},"Institut Bergonie","Bordeaux","33076","France",{"lat":330,"lon":331},44.84124,-0.58046,{"facility":333,"city":334,"zip":335,"country":328,"geoPoint":336},"Centre Leon Berard","Lyon","69008",{"lat":337,"lon":338},45.74906,4.84789,{"facility":340,"city":341,"zip":342,"country":328,"geoPoint":343},"Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole","Toulouse","31059",{"lat":344,"lon":345},43.60426,1.44367,{"facility":347,"city":348,"zip":349,"country":328,"geoPoint":350},"Institut Gustave Roussy","Villejuif","94800",{"lat":351,"lon":352},48.7939,2.35992,{"facility":354,"city":355,"zip":356,"country":357,"geoPoint":358},"Fondazione Irccs Istituto Nazionale Dei Tumori","Milan","20133","Italy",{"lat":359,"lon":360},45.46427,9.18951,{"facility":362,"city":363,"zip":364,"country":357,"geoPoint":365},"Istituto Nazionale Tumori Irccs Fondazione Pascale","Naples","80131",{"lat":366,"lon":367},40.85216,14.26811,{"facility":369,"city":370,"zip":371,"country":357,"geoPoint":372},"Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore","Rome","00168",{"lat":373,"lon":374},41.89193,12.51133,{"facility":376,"city":377,"zip":378,"country":357,"geoPoint":379},"Irccs Istituto Clinico Humanitas","Rozzano","20089",{"lat":380,"lon":381},45.38193,9.1559,{"facility":383,"city":384,"zip":385,"country":357,"geoPoint":386},"Centro Ricerche Cliniche Di Verona","Verona","37134",{"lat":387,"lon":388},45.43854,10.9938,{"facility":390,"city":391,"zip":392,"country":393,"geoPoint":394},"Aichi Cancer Center Hospital","Aichi","464 8681","Japan",{"lat":395,"lon":396},32.51879,130.62158,{"facility":398,"city":399,"zip":400,"country":393},"National Cancer Center Hospital East","Chiba-ken","277-0882",{"facility":402,"city":403,"zip":404,"country":393},"Saitama Medical University International Medical Center","Hidaka-shi","350-1298",{"facility":406,"city":407,"zip":408,"country":393,"geoPoint":409},"National Cancer Center Hospital","Tokyo","104-0045",{"lat":410,"lon":411},35.6895,139.69171,{"facility":413,"city":407,"zip":414,"country":393,"geoPoint":415},"The Cancer Institute Hospital of Jfcr","135-0063",{"lat":410,"lon":411},{"facility":417,"city":418,"zip":419,"country":420,"geoPoint":421},"Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis","Amsterdam","1066 CX","Netherlands",{"lat":422,"lon":423},52.37403,4.88969,{"facility":425,"city":426,"zip":427,"country":420,"geoPoint":428},"Erasmus Medical Center","Rotterdam","3015 GD",{"lat":429,"lon":430},51.9225,4.47917,{"facility":432,"city":433,"zip":434,"country":435,"geoPoint":436},"Panoncology Trials Pan American Center For Oncology Trials, Llc","Rio Piedras","00935","Puerto Rico",{"lat":437,"lon":438},18.39745,-66.04989,{"facility":440,"city":441,"zip":442,"country":443,"geoPoint":444},"Oncological Institute of Southern Switzerland","Bellinzona","06500","Switzerland",{"lat":445,"lon":446},46.19278,9.01703,{"facility":448,"city":449,"zip":450,"country":443,"geoPoint":451},"Inselspital Universitatsklinik Fur Medizinische Onkologie","Bern","CH-3010",{"lat":452,"lon":453},46.94809,7.44744,{"facility":455,"city":456,"zip":457,"country":443,"geoPoint":458},"Centre Hospitalier Universitaire Vaudois (Chuv)","Lausanne","01011",{"lat":459,"lon":460},46.516,6.63282,{"facility":462,"city":463,"zip":464,"country":465,"geoPoint":466},"Guys Hospital","London","SE1 9RT","United Kingdom",{"lat":467,"lon":468},51.50853,-0.12574,{"facility":470,"city":463,"zip":471,"country":465,"geoPoint":472},"Imperial College Healthcare Nhs Trust - Hammersmith Hospital","W12 0HS",{"lat":467,"lon":468},{"facility":474,"city":475,"zip":476,"country":465,"geoPoint":477},"Northern Centre For Cancer Care","Newcastle upon Tyne","NE7 7DN",{"lat":478,"lon":479},54.97328,-1.61396,[],[482],{"name":483,"affiliation":13,"role":484},"Louis Viviers, MD","STUDY_DIRECTOR",[],[487],{"label":488,"url":489},"Study of INCB123667 in Subjects with Advanced Solid Tumors","https:\u002F\u002Fincyteclinicaltrials.com\u002Fstudies\u002Fincb-123667-101",{"nct_id":4,"conditions":491,"biomarkers":502},[492,493,494,495,496,497,498,499,500,501],"Breast Carcinoma","Endometrial Carcinoma","Esophageal Carcinoma","Fallopian Tube Carcinoma","Gastric Carcinoma","GEJ Cancer","Malignant Ovarian Neoplasm","Malignant Uterine Neoplasm","Primary Peritoneal Cancer","Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]