[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhuhai Yufan Biotechnologies Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":18,"type":19},267,"ESTIMATED","INTERVENTIONAL",[22,23],"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.",[26,27],"Advanced Solid Tumor","Advanced Solid Malignancies",[29,30,31,32,33],"Maximum tolerated dose","Recommended Phase 2 dose","Dose Escalation","Hematopoietic progenitor kinase 1","PRJ1-3024","RECRUITING","2024-12-11",{"date":37,"type":38},"2024-12-17","ACTUAL",{"date":40,"type":38},"2022-05-30",{"date":42,"type":19},"2027-11-15",{"name":44,"class":45},"Zhuhai Yufan Biotechnologies Co., Ltd","INDUSTRY",5,{"id":48,"slug":4,"hasResults":10,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100572005","NCT06727630","A Phase Ib Study of PRJ1-3024 for Treatment of Advanced or Metastatic Melanoma","A Phase Ib Study, Evaluating the Safety, Tolerance and Efficacy of PRJ1-3024 Capsules in China Subjects with Unresectable Local Advanced or Metastatic Melanoma","Inclusion Criteria:• Histologically or cytologically confirmed locally advanced (unresectable) or metastatic melanoma (with the exception of ocular uveal melanoma). Patients who have progressed or relapsed after at least 1st-line systemic standard therapy.\n\n* Male or non-pregnant, non-lactating female subjects aged ≥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.\n* Adequate renal and hepatic function\n* Able to understand and willing to sign a written informed consent form.\n* Consent to provide archived tissue specimen or tissue sample.\n\nExclusion Criteria:• History of another malignancy.\n\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.\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 other hematopoietic progenitor kinase 1 (HPK1) inhibitors.\n* Allergy to the ingredients of study drug, or a history of other allergies which were judged by the investigator to be unsuitable for participation in the study.",{"count":54,"type":19},40,[22,23],"This is a Phase Ib, open-label study to determine the safety and preliminary efficacy of PRJ1-3024 in China subjects with unresectable local advanced or metastatic melanoma",[58],"Melanoma",[60],"HPK-1 inhibitor;melanoma;PRJ1-3024;Recommended Phase 2 dose","2024-12-09",{"date":35,"type":38},{"date":64,"type":38},"2024-03-14",{"date":66,"type":19},"2025-10-30",{"name":44,"class":45},1,""]