[{"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:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":19,"type":20},267,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28],"Advanced Solid Tumor","Advanced Solid Malignancies",[30,31,32,33,34],"Maximum tolerated dose","Recommended Phase 2 dose","Dose Escalation","Hematopoietic progenitor kinase 1","PRJ1-3024","RECRUITING","2024-12-11",{"date":38,"type":39},"2024-12-17","ACTUAL",{"date":41,"type":39},"2022-05-30",{"date":43,"type":20},"2027-11-15",{"name":45,"class":46},"Zhuhai Yufan Biotechnologies Co., Ltd","INDUSTRY",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100572005","phase-1-a-phase-ib-study-of-prj1-3024-for-treatment-of-advanced-or-metastatic-melanoma-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":56,"type":20},40,[23,24],"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",[60],"Melanoma",[62],"HPK-1 inhibitor;melanoma;PRJ1-3024;Recommended Phase 2 dose","2024-12-09",{"date":36,"type":39},{"date":66,"type":39},"2024-03-14",{"date":68,"type":20},"2025-10-30",{"name":45,"class":46},1,""]