[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572005":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Zhuhai Yufan Biotechnologies Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Monotherapy Escalation \u002F Monotherapy Backfill","EXPERIMENTAL","Dose escalation arm with PRJ1-3024 which will begin with 3-6 subjects treated at the lowest planned dose level based on previous phase Ia study results. PRJ1-3024 is administered orally once daily. The starting dose is 300mg\u002Fday.\n\nAfter the small dose escalation, one or two dose backfill group will be tested to further explore the efficacy and safety of China patients with unresectable local advanced or metastatic melanoma.",[13],"Drug: PRJ1-3024",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","PRJ1-3024","PRJ1-3024 is provided as capsules and is administered orally once a day",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Hui Ouyang, Dr.","VP","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Liting Lai, Bachelor","CONTACT","8617728075858","vivi.lai@ming-med.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":20,"email":51},"Jun Guo, Dr","8610-88196348","guoj307@126.com",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100572005","phase-1-a-phase-ib-study-of-prj1-3024-for-treatment-of-advanced-or-metastatic-melanoma-100572005",false,"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.","ALL","18 Years",{"count":64,"type":65},40,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE1","PHASE2","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",[72],"Melanoma",[74],"HPK-1 inhibitor;melanoma;PRJ1-3024;Recommended Phase 2 dose","2024-12-09",{"date":77,"type":78},"2024-12-11","ACTUAL",{"date":80,"type":78},"2024-03-14",{"date":82,"type":65},"2025-10-30",{"name":5,"class":6},1]