[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457617":3},{"organization":4,"armGroups":7,"interventions":97,"overallOfficials":128,"centralContacts":132,"locations":142,"responsibleParty":532,"collaborators":103,"id":534,"slug":535,"hasResults":536,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":103,"eligibilityCriteria":540,"healthyVolunteers":536,"sex":541,"minAge":542,"maxAge":103,"enrollmentInfo":543,"targetDuration":103,"studyType":546,"phases":547,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":145,"whyStopped":103,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":580},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",[8,14,18,22,26,30,34,38,43,48,53,57,62,67,72,75,79,82,85,89,93],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a Dose Escalation","EXPERIMENTAL","INCB123667 will be administered at a protocol defined starting regimen once daily (QD) orally in 28-day cycles.\n\nSubsequent dose regimens will be determined during study conduct.",[13],"Drug: INCB0123667",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1b: Dose Expansion Cohort Disease Group 1","INCB123667 will be administered at the recommended dose or doses for expansion (RDE\\[s\\]) for advanced or metastatic solid tumors. Participants with gynecologic tumors (epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma) will enroll in this group.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase 1b: Dose Expansion Cohort Disease Group 2","INCB123667 will be administered at the recommended dose or doses for expansion (RDE\\[s\\]) for advanced or metastatic solid tumors. Participants with Endometrial\u002FUterine cancer will enroll in this group.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Phase 1b: Dose Expansion Cohort Disease Group 3","INCB123667 will be administered at the recommended dose or doses for expansion (RDE\\[s\\]) for advanced or metastatic solid tumors. Participants with gastric, Gastro Esophageal Junction (GEJ), and esophageal adenocarcinomas will enroll in this group.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Phase 1b: Dose Expansion Cohort Disease Group 4","INCB123667 will be administered at the recommended dose or doses for expansion (RDE\\[s\\]) for advanced or metastatic solid tumors. Participants with Triple Negative Breast Cancer(TNBC) will enroll in this group.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Phase 1b: Dose Expansion Cohort Disease Group 5","INCB123667 will be administered at the recommended dose or doses for expansion (RDE\\[s\\]) for advanced or metastatic solid tumors. Participants with HR+\u002FHER2- breast cancer who have had disease progression on or been intolerant of a CDK4\u002F6 inhibitor will enroll in this group.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Phase 1b: Dose Expansion Cohort Disease Group 6","INCB123667 will be administered at the recommended dose or doses for expansion (RDE\\[s\\]) for advanced or metastatic solid tumors will enroll in this group.",[13],{"label":39,"type":10,"description":40,"interventionNames":41},"Phase 2a Dose Escalation Treatment Group A (TGA)","INCB123667 administered in combination with palbociclib at the recommended doses in participants with HR+\u002FHER2- breast cancer and in participants with a different tumor as defined in the protocol.",[13,42],"Drug: Palbociclib",{"label":44,"type":10,"description":45,"interventionNames":46},"Phase 2a Dose Escalation Treatment Group B (TGB)","INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses 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and in participants with a different tumor as defined in the protocol.",[13,61],"Drug: Bevacizumab",{"label":63,"type":10,"description":64,"interventionNames":65},"Phase 2a Dose Escalation Treatment Group F (TGF)","INCB123667 administered in combination with olaparib at the recommended doses in participants with HR+\u002FHER2- breast cancer and in participants with a different tumor as defined in the protocol.",[13,66],"Drug: Olaparib",{"label":68,"type":10,"description":69,"interventionNames":70},"Phase 2a Dose Escalation Treatment Group G (TGG)","INCB123667 administered in combination with paclitaxel at the recommended doses in participants with HR+\u002FHER2- breast cancer and in participants with a different tumor as defined in the protocol.",[13,71],"Drug: Paclitaxel",{"label":73,"type":10,"description":40,"interventionNames":74},"Phase 2b Dose Expansion Treatment Group H (TGH)",[13,42],{"label":76,"type":10,"description":77,"interventionNames":78},"Phase 2b Dose Expansion 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participants with gynecologic tumors (epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma) as defined by the protocol.",[13,66],{"label":94,"type":10,"description":95,"interventionNames":96},"Phase 2b Dose Expansion Treatment Group N (TGN)","INCB123667 administered in combination with weekly paclitaxel at the recommended doses in participants with gynecologic tumors (epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma) as defined by the protocol.",[13,71],[98,104,108,112,116,120,124],{"type":99,"name":100,"description":101,"armGroupLabels":102,"otherNames":103},"DRUG","INCB0123667","25 mg tablets",[9,15,19,23,27,31,35,39,44,49,54,58,63,68,73,76,80,83,86,90,94],null,{"type":99,"name":105,"description":106,"armGroupLabels":107,"otherNames":103},"Palbociclib","Palbociclib will be administered at protocol defined dose.",[39,44,73,76],{"type":99,"name":109,"description":110,"armGroupLabels":111,"otherNames":103},"Bevacizumab","Bevacizumab will be administered at protocol defined dose.",[58,86],{"type":99,"name":113,"description":114,"armGroupLabels":115,"otherNames":103},"Olaparib","Olaparib will be administered at protocol defined dose.",[63,90],{"type":99,"name":117,"description":118,"armGroupLabels":119,"otherNames":103},"Paclitaxel","Paclitaxel will be administered at protocol defined dose.",[68,94],{"type":99,"name":121,"description":122,"armGroupLabels":123,"otherNames":103},"Ribociclib","Ribociclib will be administered at protocol defined dose.",[49,54,80,83],{"type":99,"name":125,"description":126,"armGroupLabels":127,"otherNames":103},"Fulvestrant","Fulvestrant will be administered at protocol defined dose.",[44,54,76,83],[129],{"name":130,"affiliation":5,"role":131},"Liz Croft, MD","STUDY_DIRECTOR",[133,138],{"name":134,"role":135,"phone":136,"phoneExt":103,"email":137},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":139,"role":135,"phone":140,"phoneExt":103,"email":141},"Incyte 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Worth","Texas","76104",{"type":152,"coordinates":303},[304,305],-97.32085,32.72541,{"lat":305,"lon":304},{"facility":308,"status":145,"city":309,"state":310,"zip":311,"country":149,"countryCode":150,"cosmosGeoPoint":312,"geoPoint":316,"contacts":103},"Virginia Cancer Institute","Fairfax","Virginia","22031",{"type":152,"coordinates":313},[314,315],-77.30637,38.84622,{"lat":315,"lon":314},{"facility":318,"status":233,"city":319,"state":320,"zip":321,"country":149,"countryCode":150,"cosmosGeoPoint":322,"geoPoint":326,"contacts":103},"University of Wisconsin","Madison","Wisconsin","53792",{"type":152,"coordinates":323},[324,325],-89.40123,43.07305,{"lat":325,"lon":324},{"facility":328,"status":145,"city":329,"state":103,"zip":330,"country":331,"countryCode":332,"cosmosGeoPoint":333,"geoPoint":337,"contacts":103},"Institut 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Cuore","Rome","00168",{"type":152,"coordinates":390},[391,392],12.51133,41.89193,{"lat":392,"lon":391},{"facility":395,"status":145,"city":396,"state":103,"zip":397,"country":369,"countryCode":370,"cosmosGeoPoint":398,"geoPoint":402,"contacts":103},"Irccs Istituto Clinico Humanitas","Rozzano","20089",{"type":152,"coordinates":399},[400,401],9.1559,45.38193,{"lat":401,"lon":400},{"facility":404,"status":145,"city":405,"state":103,"zip":406,"country":369,"countryCode":370,"cosmosGeoPoint":407,"geoPoint":411,"contacts":103},"Centro Ricerche Cliniche Di Verona","Verona","37134",{"type":152,"coordinates":408},[409,410],10.9938,45.43854,{"lat":410,"lon":409},{"facility":413,"status":145,"city":414,"state":103,"zip":415,"country":416,"countryCode":417,"cosmosGeoPoint":418,"geoPoint":422,"contacts":103},"Aichi Cancer Center Hospital","Aichi","464 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Rico","PR",{"type":152,"coordinates":473},[474,475],-66.04989,18.39745,{"lat":475,"lon":474},{"facility":478,"status":145,"city":479,"state":103,"zip":480,"country":481,"countryCode":482,"cosmosGeoPoint":483,"geoPoint":487,"contacts":103},"Oncological Institute of Southern Switzerland","Bellinzona","06500","Switzerland","CH",{"type":152,"coordinates":484},[485,486],9.01703,46.19278,{"lat":486,"lon":485},{"facility":489,"status":145,"city":490,"state":103,"zip":491,"country":481,"countryCode":482,"cosmosGeoPoint":492,"geoPoint":496,"contacts":103},"Inselspital Universitatsklinik Fur Medizinische Onkologie","Bern","CH-3010",{"type":152,"coordinates":493},[494,495],7.44744,46.94809,{"lat":495,"lon":494},{"facility":498,"status":145,"city":499,"state":103,"zip":500,"country":481,"countryCode":482,"cosmosGeoPoint":501,"geoPoint":505,"contacts":103},"Centre Hospitalier Universitaire Vaudois (Chuv)","Lausanne","01011",{"type":152,"coordinates":502},[503,504],6.63282,46.516,{"lat":504,"lon":503},{"facility":507,"status":145,"city":508,"state":103,"zip":509,"country":510,"countryCode":511,"cosmosGeoPoint":512,"geoPoint":516,"contacts":103},"Guys Hospital","London","SE1 9RT","United Kingdom","UK",{"type":152,"coordinates":513},[514,515],-0.12574,51.50853,{"lat":515,"lon":514},{"facility":518,"status":145,"city":508,"state":103,"zip":519,"country":510,"countryCode":511,"cosmosGeoPoint":520,"geoPoint":522,"contacts":103},"Imperial College Healthcare Nhs Trust - Hammersmith Hospital","W12 0HS",{"type":152,"coordinates":521},[514,515],{"lat":515,"lon":514},{"facility":524,"status":145,"city":525,"state":103,"zip":526,"country":510,"countryCode":511,"cosmosGeoPoint":527,"geoPoint":531,"contacts":103},"Northern Centre For Cancer Care","Newcastle upon Tyne","NE7 7DN",{"type":152,"coordinates":528},[529,530],-1.61396,54.97328,{"lat":530,"lon":529},{"type":533,"investigatorFullName":103,"investigatorTitle":103,"investigatorAffiliation":103,"oldNameTitle":103,"oldOrganization":103},"SPONSOR","100457617","phase-1-study-of-incb123667-in-subjects-with-advanced-solid-tumors-100457617",false,"NCT05238922","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","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.","ALL","18 Years",{"count":544,"type":545},604,"ESTIMATED","INTERVENTIONAL",[548],"PHASE1","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).",[551],"Solid Tumors",[553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,570],"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","2026-04-10",{"date":573,"type":574},"2026-04-14","ACTUAL",{"date":576,"type":574},"2022-07-05",{"date":578,"type":545},"2027-08-31",{"name":5,"class":6},42]