[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506690":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":51,"collaborators":31,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":31,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":31,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":31,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Part1：Dose Escalation","EXPERIMENTAL","During the dose-escalation stage, an accelerated titration design (ATD) will be utilized for the first three lower dose groups (0.06, 0.12 and 0.18 mg\u002Fm\\^2). The conventional \"3+3\" dose escalation method will be used for the subsequent dose groups. The entire duration of 21 days after the first dose of ZG0895.HCl is defined as the dose-limiting toxicity (DLT) observation period.",[13],"Drug: ZG0895 Hydrochloride for Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ZG0895 Hydrochloride for Injection","The dose escalation of ZG0895.HCl is set as 0.06, 0.12, 0.18, 0.37, 0.75, 1.50, 2.25, 3.00, and 3.75 mg\u002Fm\\^2 groups, subcutaneous (SC) injection once a week (QW)",[9],[21],"ZG0895.HCl",[23],{"name":24,"affiliation":5,"role":25},"Jason Wu","STUDY_CHAIR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Wenhao Cai","CONTACT","+8615918725852",null,"caiwh@zelgen.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Zhejiang Cancer Hospital","RECRUITING","Zhejiang","Hangzhou","310022","China","CN",{"type":43,"coordinates":44},"Point",[45,46],105.583,25.3238,{"lat":46,"lon":45},[49],{"name":50,"role":29,"phone":31,"phoneExt":31,"email":31},"Ji Zhu",{"type":52,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100506690","phase-1-study-of-zg0895hcl-in-patients-with-advanced-solid-tumors-100506690",false,"NCT05877664","Study of ZG0895.HCl in Patients With Advanced Solid Tumors","A Phase 1 Dose Escalation and Expansion, Tolerability, Safety, Pharmacokinetics \u002F Pharmacodynamics and Preliminary Efficacy Study of ZG0895.HCl in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form(ICF).\n* Age ≥ 18 and ≤ 75 years old at the time of signing the ICF, either male or female;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy ≥ 3 months.\n* All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1(except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc).\n* Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.\n* For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.\n\nPart 1:\n\n* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1).\n* Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom available standard treatments failed or were intolerable.\n\nExclusion Criteria:\n\n* Participants receiving any of the following treatments:\n\n  1. Previously treated with systemic TLR7\u002F8 immunomodulators.\n  2. Any other investigational product treatment within 4 weeks before the first dosing.\n  3. Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines within 4 weeks before the first dosing. Local palliative radiotherapy, traditional Chinese medicine with anti-tumor effect, and small molecule targeted therapy within 2 weeks (or 5 half-lives, whichever is longer) before the first dosing.\n  4. Major surgery within 4 weeks before the first dosing for any reason (excluding puncture biopsy), or need to undergo elective surgery during the trial.\n  5. Potent CYP3A4\u002F5 inducer or inhibitor within 2 weeks prior to administration of the first dose of the study drug.\n  6. Systemic immunosuppressive drugs within 2 weeks prior to administration of the first dose of the study drug, including systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent).\n  7. Other immunomodulators within 2 weeks prior to administration of the first dose of the study drug, including but not limited to thymosin, interleukin-2 and interferon.\n* Had CTCAE Grade ≥3 immune-related adverse events (irAE) after receiving immunotherapy.\n* The main organ function meets any of the following criteria within 7 days prior to the first dosing. （Note: blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy are not allowed within 14 days prior to treatment.)\n\n  1. Hematological function: ANC \\\u003C 1.5×10\\^9\u002FL, PLT \\\u003C 75×10\\^9\u002FL, Hemoglobin (Hb) \\\u003C 100 g\u002FL.\n  2. Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN; ALT and AST ≥ 5×ULN for participants with liver metastases; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin \\\u003C 30 g\u002FL.\n  3. Creatinine clearance\\\u003C 75 mL\u002Fmin.\n  4. INR \\> 1.5 or APTT \\> 1.5×ULN.\n  5. The urine protein presents positive and the quantitative result of 24-h urine protein ≥ 1 g.\n* Participants with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence suggesting that the central nervous system metastasis or meningeal metastasis is not well-controlled and is judged by the investigator to be unsuitable for enrollment.\n* Uncontrollable third cavity effusion (e.g. large amount pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which is judged by the investigator to be unsuitable for enrollment.\n* Known history of neurological disorders affecting brain functional activities, including epilepsy or dementia.\n* Severe cardiac-cerebral vascular disease, including but not limited to:\n\n  1. Acute myocardial infarction, unstable angina, stroke, or received coronary angioplasty or stent implantation within 6 months before the first dosing.\n  2. New York Heart Association functional class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50% or the lower normal limit.\n  3. Uncontrollable hypertension (even though the best available treatment is used but systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n  4. QTcF interval prolongation during the baseline period.\n* Participants with active or history of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid diseases.\n* Active infection requiring systemic therapy within 7 days prior to the first dosing; active hepatitis B or hepatitis C, history of immunodeficiency virus (HIV) disease or HIV antibody positive.\n* Priorly received allogeneic stem cell transplantation or solid organ transplantation.\n* Known allergy to the ZG0895.HCl or any of its excipients; have severe allergy history (CTCAE Grade ≥ 3), such as severe urticaria, angioedema, severe anaphylaxis, etc.\n* Females who are pregnant or nursing during the screening period.\n* The investigators consider that the participants are not suitable to participate in the clinical study for other reasons.","ALL","18 Years","75 Years",{"count":64,"type":65},60,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)\u002F recommended phase 2 dose (RP2D) of ZG0895.HCl.",[71],"Advanced Solid Tumor","2024-03-04",{"date":74,"type":75},"2024-03-06","ACTUAL",{"date":77,"type":75},"2023-08-08",{"date":79,"type":65},"2026-06",{"name":5,"class":6},1]