Advanced Solid Tumors
Conditions
Interventions
Intervention group:DXC014
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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 = 18 years. 4.Life expectancy >= 3 months. 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6.Prostate Cancer: Metastatic castration-resistant prostate cancer (mCRPC) that has progressed after at least one prior line of therapy. Other Solid Tumors: Patients with advanced malignancy confirmed by histology or cytology, who have disease progression after, are intolerant to, lack standard treatment options, or are currently ineligible for standard therapy. (Standard therapy is defined as per domestic consensus guidelines [where applicable] or treatment aligned with current domestic medical practice). 7.Prostate cancer: Serum testosterone levels during screening and before the first administration of the study drug = 1 metastatic lesion(s) confirmed by baseline CT, MRI, or bone scan. The investigator will assess the appropriate cohort for the patient. Cohorts 1 and 2 are parallel and may enroll simultaneously. Other Solid Tumors: At least one measurable lesion as defined by RECIST v1.1. 9.Toxicities from prior anti-tumor therapy have recovered to Grade = 1.5 × 10^9/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 × 10^9/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) = 60 mL/min OR Serum Creatinine (Cr) = 2+ at screening, a 24-hour urine protein quantification should be performed; participants with a 24-hour urine protein = 50%. 11.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
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.Previously received B7H3-targeted therapy. 5.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. 6.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). 7.Uncontrolled diabetes mellitus. 8.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. 9.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). 10.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. 11.History of allergy to any component or excipient of DXC014. 12.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 C (HCV antibody positive and H
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose(MTD);dose-limiting toxicity(DLT); recommended Phase 2 dose(RP2D); | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics(PK);immunogenicity;clinical effect; | — |
Countries
China
Contacts
Public Contactzhengbo Song
Zhejiang Cancer Hospital
Outcome results
None listed