[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654529":3},{"organization":4,"outcomesModule":7,"designInfo":88,"detailedDescription":87,"studyPopulation":87,"armGroups":94,"interventions":101,"overallOfficials":87,"centralContacts":105,"locations":111,"responsibleParty":132,"collaborators":87,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":87,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":87,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":87,"overallStatus":114,"whyStopped":87,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Parr Biotechnology (Hebei) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":87},[9,13,17,20,23],{"measure":10,"description":11,"timeFrame":12},"DLT","Safety endpoints: incidence and severity of DLT","up to one year",{"measure":14,"description":15,"timeFrame":16},"AE","Safety endpoints: incidence and severity of adverse events (AE); Abnormal changes in laboratory and other tests with clinical significance","up to two years",{"measure":18,"description":19,"timeFrame":16},"SAE","Safety endpoints: incidence and severity of serious adverse events (SAE); Abnormal changes in laboratory and other tests with clinical significance",{"measure":21,"description":22,"timeFrame":12},"MTD","Maximum tolerated dose (MTD)",{"measure":24,"description":25,"timeFrame":12},"RP2D","Recommended dose for phase II trial",[27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84],{"measure":28,"description":29,"timeFrame":16},"ORR","Efficacy endpoints: Objective response rate (ORR) per RECIST v1.1 or mRecist 1.1 or PCWG3",{"measure":31,"description":32,"timeFrame":16},"DOR","Efficacy endpoints: Duration of response (DOR) per RECIST v1.1 or mRecist 1.1 or PCWG3",{"measure":34,"description":35,"timeFrame":16},"DCR","Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1 or mRecist 1.1 or PCWG3",{"measure":37,"description":38,"timeFrame":16},"PFS","Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1 or mRecist 1.1 or PCWG3",{"measure":40,"description":41,"timeFrame":16},"OS","Efficacy endpoints: Overall survival (OS)",{"measure":43,"description":44,"timeFrame":16},"Peak concentration（Cmax）","The pharmacokinetic parameters of WJ47156：peak concentration (Cmax)",{"measure":46,"description":47,"timeFrame":16},"the time to receive Cmax（Tmax）","The pharmacokinetic parameters of HP007：the time to receive Cmax (Tmax)",{"measure":49,"description":50,"timeFrame":16},"Area Under the plasma concentration-time curve (AUC0-t, AUC0-∞)","The pharmacokinetic parameters of HP007 ：area under the plasma concentration-time curve (AUC0-t, AUC0-∞)",{"measure":52,"description":53,"timeFrame":16},"Volume of distribution (Vd)","The pharmacokinetic parameters of HP007 ：Volume of distribution (Vd)",{"measure":55,"description":56,"timeFrame":16},"Rate of clearance (C)","The pharmacokinetic parameters of HP007 ：Rate of clearance (CL)",{"measure":58,"description":59,"timeFrame":16},"Terminal half-life (t1\u002F2)","The pharmacokinetic parameters of WJ47156 ：terminal half-life (t1\u002F2),",{"measure":61,"description":62,"timeFrame":16},"Steady-state peak concentration(Cmax,ss)","The pharmacokinetic parameters of HP007 ：steady-state peak concentration(Cmax,ss) for the main PK parameters for multiple dose",{"measure":64,"description":65,"timeFrame":16},"Plasma trough concentration at steady state(Cmin,ss)","The pharmacokinetic parameters of HP007：Plasma trough concentration at steady state(Cmin,ss) for the main PK parameters for multiple dose",{"measure":67,"description":68,"timeFrame":16},"Accumulation ratio for AUC","The pharmacokinetic parameters of HP007：Accumulation ratio of area-under-the-curve, defined as steady-state AUC within one dosing interval divided by Day 1 AUC (typically AUC₀-₂₄h). It characterizes overall systemic exposure accumulation over the dosing cycle, used for efficacy and total exposure assessment.",{"measure":70,"description":71,"timeFrame":16},"the time to receive Cmax at steady state（Tmax,ss）","The pharmacokinetic parameters of HP007 ：the time to receive Cmax at steady state（Tmax,ss）for the main PK parameters for multiple dose)",{"measure":73,"description":74,"timeFrame":16},"Area Under the plasma concentration-time curve at steady state (AUC0-t, ss)","The pharmacokinetic parameters of HP007：area under the plasma concentration-time curve at steady state (AUC0-t, ss)for the main PK parameters for multiple dose)",{"measure":76,"description":77,"timeFrame":16},"ADA","The incidence and changes of anti-drug antibody (ADA) after treatment were observed",{"measure":79,"description":80,"timeFrame":16},"Nab","The incidence and changes of neutralizing antibody (Nab) after treatment were observed",{"measure":82,"description":83,"timeFrame":12},"Cytokines","The changes of serum cytokines (IFN-α, IFN-γ, IL-6, IL-10, and chemokines IFN-γ-inducible protein 10 (IP-10) and TNF-α )in peripheral blood before and after treatment were observed",{"measure":85,"description":86,"timeFrame":12},"Subtype of lymphocyte","Flow cytometry was used to detect the changes in lymphocyte subsets in peripheral blood before and after treatment",null,{"allocation":89,"interventionModel":90,"interventionModelDescription":87,"primaryPurpose":91,"observationalModel":87,"timePerspective":87,"maskingInfo":92},"NA","SINGLE_GROUP","TREATMENT",{"masking":93,"maskingDescription":87,"whoMasked":87},"NONE",[95],{"label":96,"type":97,"description":98,"interventionNames":99},"HP007","EXPERIMENTAL","Participate will recepit HP007 monotherpy with 4 dose groups",[100],"Drug: HP007",[102],{"type":103,"name":96,"description":98,"armGroupLabels":104,"otherNames":87},"DRUG",[96],[106],{"name":107,"role":108,"phone":109,"phoneExt":87,"email":110},"Niannian Wang, Project Manager","CONTACT","+86 13161547878","niannian_wang@junshipharma.com",[112],{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"The First Hospital of Jilin University","RECRUITING","Changchun","Jilin","130000","China","CN",{"type":121,"coordinates":122},"Point",[123,124],125.32278,43.88,{"lat":124,"lon":123},[127,130],{"name":128,"role":108,"phone":87,"phoneExt":87,"email":129},"Yanhua Ding, Chief Physician","dingyanh@jlu.edu.cn",{"name":128,"role":131,"phone":87,"phoneExt":87,"email":87},"PRINCIPAL_INVESTIGATOR",{"type":133,"investigatorFullName":87,"investigatorTitle":87,"investigatorAffiliation":87,"oldNameTitle":87,"oldOrganization":87},"SPONSOR","100654529","phase-1-hp007-monotherapy-for-relapsed-or-refractory-advanced-solid-tumors-100654529",false,"NCT07800936","HP007 Monotherapy for Relapsed or Refractory Advanced Solid Tumors","Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of Intratumoral Injection of HP007 Injection as Monotherapy in Patients With Relapsed or Refractory Advanced Solid Tumors, and to Explore the Preliminary Efficacy of HP007","Inclusion Criteria:\n\n* Male\u002Ffemale, 18-75 years inclusive.\n* Histologically-confirmed unresectable advanced tumors (breast cancer, HNSCC, cutaneous melanoma, prostate cancer, HCC, etc.);\n* no effective standard therapy or disease relapse\u002Fmetastasis post-standard-of-care.\n* ECOG PS 0-1;\n* expected survival ≥3 months.\n* At least 1 measurable lesion by RECIST 1.1. Lesion in prior radiation field must have confirmed progression ≥4 weeks post-radiation. Prostate cancer subjects must meet PCWG3 progression criteria.\n* At least one lesion suitable for repeated intratumoral injection.\n* Adequate hematopoietic and organ function:\n* Males and females of child-bearing potential agree effective contraception from ICF signature to 3 months after last dose.\n* Voluntarily sign ICF and comply with study procedures.\n\nExclusion Criteria:\n\n1. Past\u002Fcurrent medical conditions\n\n   * CNS or leptomeningeal metastasis.\n   * Residual toxicity from prior anti-tumor therapy \\>Grade 1 (CTCAE 6.0), except alopecia and Grade 2 peripheral neuropathy without safety risk.\n   * Poorly controlled pleural \u002F ascitic \u002F pericardial effusion requiring local intervention or repeated drainage.\n   * Active autoimmune disease or high-risk history of recurrence; organ transplant with immunosuppression.\n   * Interstitial lung disease \u002F non-infectious pneumonitis; pulmonary embolism within prior 12 weeks.\n   * Severe cardio-cerebrovascular events within 6 months; QTcF ≥470 msec; LVEF ≤50%; NYHA ≥III heart failure; history of long-QT syndrome or ongoing QTc-prolonging drugs.\n   * Uncontrolled hypertension (SBP\\>160 mmHg and\u002For DBP\\>100 mmHg) or other uncontrolled systemic diseases.\n   * High bleeding risk \u002F coagulation disorders: inherited\u002Facquired bleeding-thrombotic predisposition; major bleeding within 3 months; thrombolytics within 10 days; ongoing anticoagulant\u002Fantiplatelet therapy (except heparin for CVC patency).\n   * Immunodeficiency; history of solid-organ or hematopoietic stem-cell transplantation.\n   * Active TB within past 5 years.\n   * Severe infection \u002F trauma \u002F GI perforation \u002F fistula \u002F tumor vascular invasion \u002F bowel obstruction within 4 weeks; active infection or antibiotic use within prior 2 weeks (prophylaxis allowed); unexplained fever \\>38.5 ℃ (tumor-related fever may be allowed per Investigator judgment).\n   * Other active malignancy within 3 years, except: cervical carcinoma in-situ, local basal-cell carcinoma, or malignancies cured ≥5 years without recurrence.\n2. Prior medications \\& treatments\n\n   * Local radiotherapy completed \\\u003C1 week before first dose; \\>30% bone-marrow \u002F extensive-field radiotherapy completed \\\u003C4 weeks before first dose.\n   * Anti-tumor therapy within 4 weeks or less than 5 half-lives (whichever shorter).\n   * Systemic corticosteroids (\\>10 mg prednisone equivalent\u002Fday) or other immunosuppressants within 14 days.\n   * Prior immunotherapy with irAEs ≥Grade 3.\n   * Prior systemic TLR-agonist treatment (topical TLR agonists e.g. imiquimod permitted).\n   * Vaccination within 1 month prior to enrolment.\n3. Allergy, general status \\& others\n\n   * Severe hypersensitivity (CTCAE 6.0 ≥Grade 3) to any investigational product component.\n   * Active HBV \u002F HCV, positive syphilis or HIV serology.\n   * Participated in another interventional clinical trial within 4 weeks.\n   * Major surgery within 4 weeks before screening or planned major surgery during study.\n   * Alcohol \u002F illicit-drug \u002F substance abuse within 12 months.\n   * Documented neurological\u002Fpsychiatric disorders leading to poor compliance.\n   * Pregnant or lactating females.\n   * Subjects judged unsuitable by the Investigator for any other reason.","ALL","18 Years","75 Years",{"count":145,"type":146},44,"ESTIMATED","INTERVENTIONAL",[149],"PHASE1","This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of HP007 monotherapy in patients with advanced malignant solid tumors.",[152],"Solid Tumors","2026-09-19",{"date":155,"type":156},"2026-09-23","ACTUAL",{"date":158,"type":156},"2026-08-17",{"date":160,"type":146},"2028-12-30",{"name":5,"class":6},1]