[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou DAC Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,62,86,110],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100641999","phase-1-dec003m-in-prostate-cancer-100641999",false,"NCT07657806","DEC003M in Prostate Cancer","A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer","Inclusion Criteria:\n\n1. At the time of informed consent, be ≥18 years of age.\n2. Histologically confirmed adenocarcinoma of the prostate.\n3. Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression despite androgen deprivation therapy.\n4. Prior orchiectomy or medical castration, or continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) .\n5. Measurable disease prior to enrollment.\n6. Testosterone at castration level.\n7. Progressed on standard therapy, or intolerant to standard therapy, or ineligible for standard therapy, or no standard therapy available.\n8. At least 1 prior Androgen Receptor Pathway Inhibitor.\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. History of other malignancies.\n2. Inadequate organ function.\n3. Active autoimmune disease.\n4. Active CNS involvement.\n5. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.\n6. Any prior medical history of ILD\u002Fpneumonitis.\n7. Clinically significant corneal disorder or known severe dry eye.\n8. Grade 2 or higher peripheral neuropathy.\n9. Inadequate washout period for prior anticancer treatment.\n10. Any known history of or suspicion for history of clinically significant liver disease .\n11. Known hypersensitivity to any component of the DEC003M.\n12. Prior treatment with a PSMA-targeted antibody therapy.\n13. Other conditions judged by the investigator that may have effects on the patient's participation in the study.","MALE","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open-label, multicenter Phase 1 study of DEC003M, in patients with advanced stage prostate cancer. The study consists of a dose-escalation phase to determine the dose for expansion, followed by a dose-expansion phase to evaluate preliminary antitumor activity, safety, and pharmacokinetics.",[26],"Advanced Prostate Cancer","NOT_YET_RECRUITING","2026-06-17",{"date":30,"type":31},"2026-06-22","ACTUAL",{"date":33,"type":20},"2026-08-01",{"date":35,"type":20},"2031-05-01",{"name":37,"class":38},"Hangzhou DAC Biotechnology Co., Ltd.","INDUSTRY",4,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":5},"100533364","phase-1-a-study-of-dxc006-in-patients-with-advanced-solid-tumors-and-hematologic-malignancies-100533364","NCT06224855","A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies","An Open-label Dose Escalation and Cohort Expansion Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and and Efficacy of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies","Inclusion Criteria:\n\n1. The patient voluntarily signed the informed consent form and followed the protocol requirements.\n2. Gender is not limited.\n3. Age ≥ 18 years old.\n4. Expected survival time ≥ 3 months.\n5. The Eastern Cooperative Oncology Group (ECOG) score 0-2.\n6. Subjects may provide biopsy or archival tumor tissue samples for the central laboratory to confirm expression levels of Target protein.\n7. Patients with solid tumors or hematologic tumors who have failed standard therapy, including small cell lung cancer, multiple myeloma, neuroblastoma, etc..\n8. Patients who have received ASCT treatment must meet the following conditions:\n\n   1. ASCT \\> 100 days from start of study treatment.\n   2. no active infection.\n9. Toxicity from prior antineoplastic therapy has recovered to Grade ≤ 1 (except alopecia) as defined by NCI-CTCAE v5.0, including peripheral neuropathy ≤ Grade 2.\n10. Organ function must meet the following requirements: blood routine:\n\n(1) Patients with multiple myeloma: absolute neutrophil count (ANC) ≥ 1.0×109\u002FL (previous use of granulocyte colony-stimulating factor \\[G-CSF\\] is allowed, and G-CSF is not allowed within 7 days before laboratory examination during the screening period);Platelet count ≥ 50×109\u002FL (platelet transfusion is not allowed within 7 days before laboratory tests during the screening period).\n\nHemoglobin (HGB) ≥ 75 g\u002FL (prior red blood cell \\[RBC\\] transfusions or recombinant human erythropoietin are allowed; Within 7 days before the laboratory examination during the screening period, red blood cell transfusion is not allowed).\n\n(2) Other patients: Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, Platelet count ≥ 100×109\u002FL, Hemoglobin (HGB) ≥ 90 g\u002FL Liver: total bilirubin (TBIL) ≤ 1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert's syndrome (direct bilirubin ≤ 1.5×ULN); Glutamate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 3.0×ULN.\n\nIn the presence of liver metastases, both AST and ALT ≤ 5× ULN Kidney: creatinine clearance (Ccr) ≥ 30mL\u002Fmin in patients with multiple myeloma, Creatinine ≤ 1.5×ULN in other patients.\n\nCoagulation:\n\nInternational Normalized Ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) or prothrombin time (PT) ≤ 1.5× ULN.\n\ncorrected serum calcium ≤ 14 mg\u002FdL (≤ 3.5 mmol\u002FL). left ventricular ejection fraction (LVEF) ≥ 50%. 11. The patient and his\u002Fher spouse agree to take effective contraceptive measures (excluding contraception during the safe period) from the time of signing the informed consent form to 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Within 14 days before the first dose: received plasmapheresis; Treatment with \\> 10 mg of prednisone or equivalent doses of systemic corticosteroids per day for more than 3 consecutive days (short-term use for the prevention of contrast allergy can be enrolled).\n2. Patients have received systemic anti-myeloma therapy or investigational drug therapy within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; Radiotherapy within 14 days prior to the first dose.\n3. Patients have received monoclonal antibody therapy within 30 days before the first dose.\n4. Patients have received autologous hematopoietic stem cell transplantation within 100 days before the first dose.\n5. Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) or have a history of solid organ transplantation.\n6. Patients have received the same targeted therapy in the past (limited to phase Ia clinical trials).\n7. Patient has symptomatic brain metastases or meningeal metastases.\n8. The patient had symptomatic amyloidosis, active plasma cell leukemia, and active POEMS syndrome at the time of screening.\n9. There is evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 ms (QT interval must be corrected by Fridericia formula \\[QTcF\\]). b. Evidence of currently clinically significant, untreated arrhythmias, including clinically significant electrocardiogram abnormalities such as degree 2 (Mobitz type II) or degree 3 atrioventricular conduction (AV) block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty, or stenting or bypass grafting within 6 months prior to screening. d. Grade III or IV heart failure(New York Heart Association Functional Grading System). e. Uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n10. The patient has difficulty breathing or currently requires continuous oxygen therapy, or currently has active pneumonia or interstitial lung disease (except for mild cases as determined by the investigator).\n11. The patient has a history of other primary malignancies, except the following: cured malignancies with a very low risk of recurrence within 5 years, such as skin basal cell carcinoma and skin squamous cell carcinoma, carcinoma in situ of the cervix or breast.\n12. Patients have severe unhealed wound ulcers or fractures, or have undergone major surgery within 28 days prior to dosing or are expected to undergo surgery during the clinical study.\n13. Previous history of allergy to any component or excipient of DXC006.\n14. Active hepatitis B (HBV-DNA greater than the central upper limit of normal or HBV-DNA testing greater than 1000 copies \u002FmL); Hepatitis C infection (positive for hepatitis C antigen or positive for hepatitis C RNA PCR).\n15. Seropositive for human immunodeficiency virus (HIV); Active syphilis (patients with positive syphilis antibodies can be included); Possible active tuberculosis (chest imaging within 3 months prior to first dosing indicating active tuberculosis infection).\n16. Patients had active bleeding within 30 days prior to screening, or were at risk of massive gastrointestinal bleeding or hemoptysis as determined by researchers; Or have inherited bleeding tendencies or coagulation disorders, or bleeding symptoms that require other medical intervention.\n17. Severe arteriovenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first dose.\n18. Female patients with a positive serological pregnancy test or who are breastfeeding.\n19. Active infections requiring medical treatment (CTCAE≥2); Uncontrollable pleural fluid, ascites, pericardial effusion requiring repeated drainage;\n20. Received live attenuated vaccine within 28 days before the first dose.\n21. The patient has other conditions that the investigator or sponsor has determined may affect the study.","ALL",{"count":49,"type":20},280,[23],"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 DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.",[53,54],"Advanced Solid Tumors","Hematological Malignancies","RECRUITING",{"date":30,"type":31},{"date":58,"type":31},"2024-01-24",{"date":60,"type":20},"2027-12-31",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100635995","phase-1-a-study-of-dxc006-with-immune-checkpoint-inhibitors-or-platinum-for-small-cell-lung-cancer-100635995","NCT07559929","A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.","A Phase Ib\u002FII Study to Evaluate the Safety and Efficacy of DXC006 for Injection Combined With Immune Checkpoint Inhibitors or Platinum-Based Agents in Patients With Small Cell Lung Cancer.","Inclusion Criteria:\n\n1. Voluntarily signed informed consent and willingness to comply with the protocol requirements.\n2. Male or female.\n3. Age ≥18 years and ≤75 years.\n4. Life expectancy ≥3 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n6. Histologically or cytologically confirmed small cell lung cancer (SCLC).\n7. Toxicity from prior anti-tumor therapy has resolved to ≤ Grade 1 as defined by NCI-CTCAE version 6.0 (except alopecia); peripheral neuropathy must have completely resolved.\n8. Adequate hepatic, renal, coagulation, and cardiac function.\n9. The participant and their spouse agree to use effective barrier or pharmacologic contraception (excluding rhythm method) from the time of signing the informed consent until 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed combined SCLC, NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma.\n2. Within 14 days prior to the first dose: underwent plasmapheresis; received systemic corticosteroid therapy at a daily dose \\>10 mg prednisone or equivalent (or equivalent anti-inflammatory activity) for more than 3 consecutive days (short-term use for prevention of contrast media allergy is permitted).\n3. Prior allogeneic hematopoietic stem cell transplantation (HSCT) or history of solid organ transplantation.\n4. Prior treatment with CD56-targeted therapy.\n5. Symptomatic brain metastases or leptomeningeal metastases.\n6. History of severe or life-threatening immune-related adverse events or infusion-related reactions (including permanent discontinuation of immuno-oncology therapy due to intolerance).\n7. Active autoimmune disease or immunodeficiency, or a history of such conditions.\n8. Evidence of significant cardiovascular risk.\n9. Dyspnea or current requirement for continuous supplemental oxygen therapy, or current active pneumonitis or interstitial lung disease (except mild cases as determined by the investigator).\n10. History of other primary malignancies, with the exception of malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.\n11. Severe non-healing wound, ulcer, or bone fracture; or major surgery within 28 days prior to dosing, or anticipated major surgery during the study period.\n12. History of hypersensitivity to any component or excipient of DXC006, immune checkpoint inhibitors, or platinum-based chemotherapy.\n13. Active hepatitis B (HBV-DNA above the upper limit of normal at the central laboratory or \\>1000 copies\u002FmL); hepatitis C infection (positive hepatitis C antibody or positive HCV RNA PCR result).\n14. Known positive serology for human immunodeficiency virus (HIV); active syphilis (patients with positive syphilis antibody only are eligible); potential active pulmonary tuberculosis (chest imaging within 3 months prior to the first dose suggestive of active tuberculosis infection).\n15. Active bleeding within 30 days prior to screening, or risk of major gastrointestinal bleeding or hemoptysis as determined by the investigator; or hereditary bleeding tendency, coagulopathy, or bleeding symptoms requiring other medical intervention.\n16. Severe arterial or venous thromboembolic events within 6 months prior to study drug administration, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.\n17. Positive serum pregnancy test or currently breastfeeding female participants.\n18. Active infection requiring medical therapy (CTCAE Grade ≥2); uncontrollable pleural effusion, ascites, or pericardial effusion requiring repeated drainage.\n19. Administration of live attenuated vaccines within 28 days prior to the first dose.\n20. Other conditions that, in the judgment of the investigator, may affect the patient's participation in the study.\n21. Poor general condition, such as requirement for mechanical ventilation and\u002For intravenous catecholamine infusion, and\u002For severe neurological impairment, coma, and\u002For quadriplegia with complete loss of communication ability (deafness, blindness, aphasia); uncontrolled seizures; other psychiatric disorders that may affect study participation.","75 Years",{"count":71,"type":20},200,[23,73],"PHASE2","This is a Phase Ib\u002FII, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).",[76],"Small Cell Lung Cancer","2026-05-27",{"date":79,"type":31},"2026-05-29",{"date":81,"type":20},"2026-06-01",{"date":83,"type":20},"2030-12-30",{"name":37,"class":38},1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100606621","phase-1-a-study-of-dxc014-in-patients-with-advanced-solid-tumors-100606621","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.",{"count":94,"type":20},150,[23],"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.",[76,98,99,100],"Melanoma","Prostate Cancer","Other Advanced Solid Tumors","2026-04-23",{"date":103,"type":31},"2026-04-24",{"date":105,"type":31},"2026-03-03",{"date":107,"type":20},"2030-10-20",{"name":37,"class":38},3,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":69,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":109},"100587276","phase-1-a-study-of-dxc008-in-patients-with-prostate-cancer-and-other-solid-tumors-100587276","NCT06926283","A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors","A Phase I, Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (Such as Ewing Sarcoma)","Inclusion Criteria:\n\n1. Those who voluntarily sign the ICF and follow the protocol requirements.\n2. Male or female.\n3. Age: ≥ 18 years and ≤ 75 years.\n4. Expected life expectancy ≥ 6 months.\n5. ECOG performance status score: 0-2.\n6. Patients with various solid tumors who have failed standard treatment, including but not limited to progressive mCRPC.\n7. Serum testosterone level during screening and prior to the first dose of investigational product: ≤50 ng\u002FdL (≤1.73 nmol\u002FL).\n8. Cohort 1: at least one measurable lesion as defined by RECIST v1.1. Cohort 2: at least one metastatic lesion on CT\u002FMRI, or bone scan imaging at baseline. Patients are assigned to the appropriate cohort as assessed by the investigator, the study procedures in Cohort 1 and Cohort 2 may be performed in parallel and simultaneously, it is not necessary to wait until all procedures in either cohort have been completed before initiating procedures in the other cohort.\n9. Toxicities from prior antitumor therapy must have recovered to Grade ≤ 1 as defined in the NCI-CTCAE v5.0 (except alopecia), or Grade 2 as defined by NCI-CTCAE v5.0, except for toxicity not constituting a safety risk by investigator judgment (eg, Grade 2 peripheral neurotoxicity).\n10. Organ function of the subjects must meet the following requirements:\n\nHematology:\n\n1. ANC ≥ 1.5 × 10\\^9\u002FL (prior use of G-CSF is allowed, but G-CSF use is not allowed within 7 days prior to the screening laboratory tests).\n2. Platelet count ≥100×10\\^9\u002FL (platelet transfusion is not allowed within 7 days before the screening laboratory tests).\n3. HGB ≥ 90 g\u002FL (RBC transfusion or recombinant human erythropoietin use is allowed; RBC transfusion is not allowed within 7 days prior to the screening laboratory tests).\n\nLiver function:\n\n1. Total bilirubin (TBIL) ≤1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤1.5×ULN).\n2. AST and ALT ≤ 3.0 × ULN. For patients with liver metastases, both AST and ALT ≤5×ULN.\n\nRenal function:\n\nCcr ≥ 60 mL\u002Fmin; or creatinine ≤ 1.5 × ULN; urinalysis results show protein urine ≤ 1 +.\n\nFor subjects with urine protein ≥2+ in urinalysis during the screening period, a 24-hour urine protein quantification should be performed, and those with 24-hour urine protein quantification ≤1 g can be enrolled.\n\nCoagulation function:\n\n1. INR≤1.5.\n2. APTT or PT ≤ 1.5 × ULN. LVEF≥50%. 11.Subjects and their spouses agree to use effective instrumental or pharmacologic contraception (excluding safe period contraception) from the time of ICF signing until 6 months after the last dose of investigational product.\n\nExclusion Criteria:\n\n1. Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at \\> 10 mg\u002Fday for \\> 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication (Those who have received short-term treatment with such medications for the prevention of contrast media allergy may be enrolled).\n2. Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose, have received radiotherapy within 14 days prior to the first dose.\n3. Have received monoclonal antibody treatment within 30 days prior to the first dose.\n4. History of solid organ transplantation.\n5. Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only).\n6. Presence of meningeal or brain metastases.\n7. Evidence of cardiovascular risk, including any of the following:\n\n   1. QTcF interval ≥ 470 msec (QT interval must be corrected for heart rate using the Fridericia formula \\[QTcF\\]).\n   2. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular (AV) block.\n   3. Within 6 months before screening, history of myocardial infarct, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty or stent implantation, or bypass grafting.\n   4. Class III or IV heart failure - as defined by the New York Heart Association Functional Classification.\n   5. Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg.\n8. Have dyspnea or any current condition that needs continuous oxygen therapy, or current active pneumonia or interstitial lung diseases (except mild cases as judged by the investigator).\n9. History of other primary malignancies, except for the following: malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.\n10. Have severe unhealed wound, ulceration or bone fracture, or have received major surgery within 28 days prior to administration or expected major surgery during the clinical study.\n11. Prior history of allergy to any component or excipient of DXC008.\n12. Active hepatitis B with HBV-DNA greater than central upper limit of normal or greater than 1000 copies\u002FmL, active hepatitis C (Hepatitis C virus antibody positive with HCV RNA greater than lower limit of detection value).\n13. Known to be seropositive for the HIV; have active syphilis (only patients with a positive syphilis antibody are eligible for enrollment in the study), possible presence of active tuberculosis (chest imaging within 3 months prior to the first dose indicates active tuberculosis infection).\n14. Patients with active bleeding within 30 days before screening, or, judged by the investigator, to be at risk of massive digestive tract hemorrhage, hemoptysis, etc.; or with hereditary bleeding tendency or coagulation disorder, or bleeding symptoms requiring other medical intervention.\n15. Have experienced serious arterial\u002Fvenous thrombosis events within 6 months prior to the first dose, such as cerebrovascular accident (including transient cerebral ischemic attack), deep venous thrombosis, pulmonary embolism.\n16. Female subjects with positive serum pregnancy test or who are breastfeeding.\n17. Those with active infection requiring drug intervention (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment, uncontrollable pleural effusion, ascites, pericardial effusion requiring repeated drainage.\n18. Have received vaccination with live attenuated vaccine within 28 days prior to the first dose or planned to receive such vaccination during the study period.\n19. Patients with other conditions judged by the investigator that may have adverse effect on the patient's participation in the study.",{"count":19,"type":20},[23],"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 DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma.",[99,121,122],"Other Solid Tumors","Ewing Sarcoma",{"date":103,"type":31},{"date":125,"type":31},"2025-05-15",{"date":127,"type":20},"2030-04",{"name":37,"class":38},""]