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A Study of DXC014 in Patients With Advanced Solid Tumors.

RecruitingPhase 1Ages 18 Years - anyAllHangzhou DAC Biotechnology Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements. 2. Male or female. 3. For other solid tumor patients: Age ≥18 years and ≤75 years;For prostate cancer patients: Age ≥18 years. 4 .Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6\. 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. Other 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. 9\. Adequate organ function as defined by the following laboratory values: Hematological:(1) Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L (No use of G-CSF or granulocyte-/white blood cell-boosting drugs within 7 days prior to the screening lab test). (2) Platelet count ≥ 100 × 10⁹/L (No platelet or whole blood transfusion or platelet-boosting drugs within 7 days prior to the screening lab test). (3) Hemoglobin (HGB) ≥ 90 g/L (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/min 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%. 10\. 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. Exclusion Criteria: 1. Within 14 days prior to the first dose: Underwent plasmapheresis; received systemic corticosteroid therapy at a dose \>10 mg/day 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). 2. 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. 3. History of solid organ transplantation. 4. Prostate Cancer: Leptomeningeal metastasis or brain metastasis. Other Solid Tumors: Participants with active central nervous system (CNS) metastases and/or 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. 5. 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). 6. Uncontrolled diabetes mellitus. 7. 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. 8. 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\]. 9. 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. 10. History of allergy to any component or excipient of DXC014 . 11. Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL or above the upper limit of normal \[ULN\] of the testing unit); active hepatitis
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What it tests

  • DXC014
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Where

5 sites
Peking University First Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Zhejiang Cancer Hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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