[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"other-advanced-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:other-advanced-solid-tumors":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100606621","phase-1-a-study-of-dxc014-in-patients-with-advanced-solid-tumors-100606621",false,"NCT07177937","A Study of DXC014 in Patients With Advanced Solid Tumors.","An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Expansion Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of DXC014 for Injection in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements.\n2. Male or female.\n3. For other solid tumor patients: Age ≥18 years and ≤75 years；For prostate cancer patients: Age ≥18 years.\n\n4 .Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\n6\\. Prostate cancer,other solid tumors. 7. Prostate Cancer (Two Parallel Cohorts): Cohort 1: At least one measurable lesion as defined by RECIST v1.1. Cohort 2: Presence of ≥1 metastatic lesion(s) confirmed by baseline CT, MRI, or bone scan.Participants and their partners agree to use effective methods of contraception (excluding the rhythm method) from the time of signing the informed consent form until 6 months after the last dose of study drug.\n\nOther Solid Tumors: At least one measurable lesion as defined by RECIST v1.1. 8. Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 as defined by NCI-CTCAE v5.0 (except alopecia). Grade 2 toxicities per NCI-CTCAE v5.0 may be permitted if judged by the investigator to pose no safety risk.\n\n9\\. Adequate organ function as defined by the following laboratory values: Hematological:(1) Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL (No use of G-CSF or granulocyte-\u002Fwhite blood cell-boosting drugs within 7 days prior to the screening lab test). (2) Platelet count ≥ 100 × 10⁹\u002FL (No platelet or whole blood transfusion or platelet-boosting drugs within 7 days prior to the screening lab test). (3) Hemoglobin (HGB) ≥ 90 g\u002FL (No red blood cell (RBC) or whole blood transfusion or hemoglobin-boosting drugs within 7 days prior to the screening lab test).Hepatic: (1) Total Bilirubin (TBIL) ≤ 1.5 × ULN (Upper Limit of Normal); except for participants with congenital bilirubinemia, e.g., Gilbert's syndrome (Direct bilirubin ≤ 1.5 × ULN). (2) AST and ALT ≤ 3.0 × ULN. (3) AST and ALT ≤ 5.0 × ULN in the presence of liver metastases. Renal: Creatinine Clearance (Ccr) ≥ 60 mL\u002Fmin OR Serum Creatinine (Cr) ≤ 1.5 × ULN. For participants with urinalysis showing urine protein ≥ 2+ at screening, a 24-hour urine protein quantification should be performed; participants with a 24-hour urine protein ≤ 1 g may be enrolled. Coagulation: (1) International Normalized Ratio (INR) ≤ 1.5. (2) Activated Partial Thromboplastin Time (APTT) or Prothrombin Time (PT) ≤ 1.5 × ULN. Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n\n10\\. Participants and their partners agree to use effective methods of contraception (excluding the rhythm method) from the time of signing the informed consent form until 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Within 14 days prior to the first dose: Underwent plasmapheresis; received systemic corticosteroid therapy at a dose \\>10 mg\u002Fday prednisone or equivalent for more than 3 consecutive days, or other anti-inflammatory drugs with equivalent activity (short-term use for preventing contrast agent allergy is allowed for enrollment).\n2. Received systemic anti-tumor therapy or investigational drug treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; received palliative radiotherapy within 14 days prior to the first dose; received treatment with Chinese patent medicines or herbal medicines explicitly indicated for anti-tumor purposes in the NMPA-approved drug label within 1 week prior to the first dose.\n3. History of solid organ transplantation.\n4. Prostate Cancer: Leptomeningeal metastasis or brain metastasis. Other Solid Tumors: Participants with active central nervous system (CNS) metastases and\u002For leptomeningeal metastases or spinal cord compression, with the following exceptions: asymptomatic and stable brain metastases, or participants who have received treatment for brain metastases with no evidence of new or enlarging brain metastases on imaging for at least 4 weeks and no related symptoms, and who have discontinued steroid or anticonvulsant therapy for at least 14 days prior to initiation of study treatment.\n5. Evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 milliseconds (QT interval must be corrected using Fridericia's formula \\[QTcF\\]). b. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd-degree (Mobitz Type II) or 3rd-degree atrioventricular block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to screening. d. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. e. Uncontrolled severe hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n6. Uncontrolled diabetes mellitus.\n7. Current interstitial lung disease or pulmonary fibrosis, pneumoconiosis, radiation pneumonitis, severely impaired pulmonary function, or other conditions that may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n8. History of or current other malignancies within the past 5 years. Participants may be enrolled in the following two scenarios: other malignancies treated with single surgery alone, achieving continuous 5-year disease-free survival (DFS); adequately treated carcinoma in situ with no evidence of recurrence, such as cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\\].\n9. Presence of severe unhealed wounds, ulcers, or fractures; major surgery within 28 days prior to the first dose or anticipated major surgery during the clinical study period.\n10. History of allergy to any component or excipient of DXC014 .\n11. Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU\u002FmL or above the upper limit of normal \\[ULN\\] of the testing unit); active hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection).\n12. Known positive HIV serology; active syphilis (participants with only a positive syphilis antibody test may be enrolled); suspected active tuberculosis (chest imaging within 3 months prior to the first dose suggests active tuberculosis infection).\n13. Active bleeding within 30 days prior to screening, or judged by the investigator to be at risk of major gastrointestinal bleeding, hemoptysis, etc.; or hereditary bleeding tendency or coagulation dysfunction; or hemorrhagic symptoms requiring other medical intervention.\n14. History of severe arterial\u002Fvenous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism.\n15. Female participants who are pregnant (positive serum pregnancy test) or breastfeeding.\n16. Active infection requiring systemic medication (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment; uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage.\n17. Administration of a live attenuated vaccine within 28 days prior to the first dose or planned vaccination during the study period.\n18. Any other condition that, in the judgment of the investigator or sponsor, may affect the participant's participation in this study.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC014 in patients with Advanced Solid Tumors.",[26,27,28,29],"Small Cell Lung Cancer","Melanoma","Prostate Cancer","Other Advanced Solid Tumors","RECRUITING","2026-04-23",{"date":33,"type":34},"2026-04-24","ACTUAL",{"date":36,"type":34},"2026-03-03",{"date":38,"type":20},"2030-10-20",{"name":40,"class":41},"Hangzhou DAC Biotechnology Co., Ltd.","INDUSTRY",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100590697","phase-1-a-study-of-sys6040-for-injection-in-patients-with-advanced-solid-tumors-100590697","NCT06970795","A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors","An Open-lable, Multicenter Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6040 for Injection as a Single Agent in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1）Aged ≥18 years; 2) Subjects with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, are intolerant to standard therapy, or have no options of standard of care. During cohort expansion, subjects will be enrolled as follows: Cohort 1: SCLC subjects who failed or were intolerant to at least one prior platinum-containing chemotherapy regimen; Cohort 2: Subjects with DLL3-positive malignant solid tumors who failed standard therapy, are intolerant to standard therapy, or have no options of standard of care.\n\n3\\) At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 4) ECOG score of 0 or 1; 5) Life expectancy ≥3 months; 6) Laboratory parameters meeting the following criteria:\n\n1. Neutrophil count ≥1.5×109\u002FL;\n2. Platelet count ≥100×109\u002FL;\n3. Hemoglobin ≥9 g\u002FdL;\n4. Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (In cases with liver metastases: total bilirubin ≤3×ULN and ALT\u002FAST ≤5×ULN);\n5. Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin;\n6. International Standardized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.\n\na. Fertile males and females must use reliable contraception throughout the study period and for 9 months after the last dose. Females aged 18-60 years must have negative blood pregnancy results within 7 days before the first dose.\n\n7\\) Understand and voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Having received systemic antitumor therapy within 4 weeks before first dose, including: Chemotherapy, macromolecular targeted therapy, antiangiogenic therapy, biotherapy, immunotherapy, radiotherapy (except palliative radiotherapy for bone metastasis pain relief), except:\n\n   1. Oral fluorouracil agents and small molecule targeted drugs within 2 weeks before first dose or within 5 half-lives (whichever is longer);\n   2. Traditional Chinese medicines with antitumor indications within 2 weeks before first dose.\n2. Used or required to use strong CYP3A4 inhibitors\u002Finducers within 2 weeks before first dose or during the study;\n3. Previous treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors as payload;\n4. Having received systemic corticosteroid therapy (\\>10 mg prednisone equivalent daily for \\>7 days) or other immunosuppressants within 2 weeks before treatment initiation (inhaled\u002Ftopical steroids or adrenal replacement therapy \\>10 mg prednisone equivalent permitted without active autoimmune disease);\n5. Having received transfusion, EPO, TPO, IL-11, G-CSF or GM-CSF therapy within 2 weeks before first dose;\n6. Having used or required to use QT-prolonging\u002Fshortening drugs within 7 days before first dose or during C-QTc study period, or have risk factors for QT prolongation\u002Farrhythmia (e.g., heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in first-degree relatives \\\u003C40 years);\n7. Severe cardiovascular\u002Fcerebrovascular disease history；\n8. History of other primary malignancies (except cured localized tumors like basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate\u002Fcervix\u002Fbreast, or subjects with other primary tumors showing no recurrence for ≥5 years);\n9. Clinically confirmed active pneumonia at screening or history of interstitial lung disease;\n10. Uncontrolled serous effusions requiring frequent drainage or medical intervention at screening (e.g., pleural\u002Fperitoneal\u002Fpericardial effusions needing additional intervention within 2 weeks after initial treatment, excluding cytological examination);\n11. Brain metastases or spinal cord compression at screening (except those completing local therapy with ≥4-week steroid discontinuation and stable imaging\u002Fneurological symptoms for ≥4 weeks before treatment initiation);\n12. Severe unhealed wounds\u002Fulcers\u002Ffractures, or major surgery within 4 weeks before first dose, or planned elective surgery during study;\n13. Clinically confirmed active HBV or HCV.Active HBV definition: HBcAb or HBsAg positive with HBV DNA above ULN; Active HCV definition: HCV antibody positive with HCV RNA above ULN;\n14. Active tuberculosis confirmed clinically, or TP-Ab positive, or HIV-Ab positive, or history of immunodeficiency diseases\u002Forgan transplantation\u002Fallogeneic hematopoietic stem cell transplantation;\n15. Significant bleeding tendency within 4 weeks before first dose, investigator-assessed high-risk of gastrointestinal hemorrhage\u002Fhemoptysis, or congenital bleeding disorders\u002Fcoagulopathy;\n16. Active infection requiring medication or unexplained fever ≥38.5°C during screening;\n17. History of psychotropic substance abuse, alcoholism, or drug addiction;\n18. Pregnancy or lactation at screening;\n19. Persistent adverse reactions from prior antitumor therapy not recovered to CTCAE v5.0 ≤Grade 1 or baseline (except alopecia\u002Fnail changes\u002Fother investigator-deemed non-safety concerns);\n20. Investigator-determined ineligibility for study participation.",{"count":51,"type":20},180,[23],"This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).The planned study population consists of subjects with advanced solid tumors.The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SYS6040 for injection as monotherapy in participants with advanced solid tumors.",[26,29],"2025-05-06",{"date":57,"type":34},"2025-05-14",{"date":59,"type":34},"2025-04-10",{"date":61,"type":20},"2028-11-30",{"name":63,"class":41},"CSPC Megalith Biopharmaceutical Co.,Ltd.",1]