[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463474":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":99,"collaborators":24,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":24,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":24,"enrollmentInfo":110,"targetDuration":24,"studyType":113,"phases":114,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Zhuhai Yufan Biotechnologies Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Monotherapy Escalation","EXPERIMENTAL","3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level. PRJ1-3024 is administered orally once daily. The starting dose is 80mg\u002Fday.",[13],"Drug: PRJ1-3024",{"label":15,"type":10,"description":16,"interventionNames":17},"Monotherapy Exploration of the recommended dose","Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 with several cohorts enrolled to confirm the tolerability of the RP2D of PRJ1-3024 (determined in Phase 1). PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue for up to 2 years as long as the subject experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","PRJ1-3024","PRJ1-3024 is provided as capsules and is administered orally once a day.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Hui ouyang, Dr.","VP","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Liting Lai","CONTACT","8617728075858","vivi.lai@ming-med.com",[37,53,65,77,91],{"facility":38,"status":39,"city":40,"state":41,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The first affiliated hospital of Zhengzhou University","RECRUITING","Zhengzhou","Henan","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.64861,34.75778,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":24,"phoneExt":24,"email":24},"Yanru Qin",{"facility":54,"status":39,"city":55,"state":56,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"West China Hospital of Sichuan University","Chengdu","Sichuan",{"type":45,"coordinates":58},[59,60],104.06667,30.66667,{"lat":60,"lon":59},[63],{"name":64,"role":33,"phone":24,"phoneExt":24,"email":24},"Yongsheng Wang",{"facility":66,"status":39,"city":67,"state":68,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Cancer hospital of the University of Chinese Academy of Sciences","Hangzhou","Zhejiang",{"type":45,"coordinates":70},[71,72],120.16142,30.29365,{"lat":72,"lon":71},[75],{"name":76,"role":33,"phone":24,"phoneExt":24,"email":24},"Ji Zhu",{"facility":78,"status":39,"city":79,"state":24,"zip":80,"country":42,"countryCode":43,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Beijing Cancer Hospital","Beijing","100142",{"type":45,"coordinates":82},[83,84],116.39723,39.9075,{"lat":84,"lon":83},[87],{"name":88,"role":33,"phone":89,"phoneExt":24,"email":90},"Lin Shen, Dr.","8610-88196561","doctorshenlin@sina.com",{"facility":92,"status":39,"city":79,"state":24,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"The Fifth Medical Center of PLA General Hospital",{"type":45,"coordinates":94},[83,84],{"lat":84,"lon":83},[97],{"name":98,"role":33,"phone":24,"phoneExt":24,"email":24},"Guanghai Dai",{"type":100,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100463474","phase-1-a-phase-iii-study-to-evaluate-the-safety-pharmacokinetics-and-efficacy-of-prj1-3024-in-subjects-with-advanced-solid-tumors-100463474",false,"NCT05315167","A Phase I\u002FII Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors","A Phase 1\u002F2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors","\\- Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r\u002Fr solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.\n* Male or non-pregnant, non-lactating female subjects age ≥18 years.\n* ECOG Performance Status 0\\~1.\n* Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .\n* Life expectancy of \\>3 months, in the opinion of the Investigator.\n* Able to take oral medications and willing to record daily adherence to investigational product.\n* Adequate hematologic parameters unless clearly due to the disease under study.\n* Adequate renal and hepatic function\n* Able to understand and willing to sign a written informed consent form.\n\nKey Exclusion Criteria:\n\n* History of another malignancy\n* Known symptomatic brain metastases requiring \\>10 mg\u002Fday of prednisolone.\n* Significant cardiovascular disease.\n* Known active HBV, HCV, AIDS-related illness.\n* Has received a live vaccine within 30 days.\n* History of active autoimmune disorders, or ongoing immunosuppressive therapy or ongoing .\n* Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \\\u003C Grade 2.\n* Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .\n* Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.","ALL","18 Years",{"count":111,"type":112},267,"ESTIMATED","INTERVENTIONAL",[115,116],"PHASE1","PHASE2","This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed\u002Frefractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.",[119,120],"Advanced Solid Tumor","Advanced Solid Malignancies",[122,123,124,125,21],"Maximum tolerated dose","Recommended Phase 2 dose","Dose Escalation","Hematopoietic progenitor kinase 1","2024-12-11",{"date":128,"type":129},"2024-12-17","ACTUAL",{"date":131,"type":129},"2022-05-30",{"date":133,"type":112},"2027-11-15",{"name":5,"class":6},5]