Advanced malignant solid tumor
Conditions
Interventions
Experimental group:BC3448 intravenous administration
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Patients with histologically or cytologically confirmed local recurrent or metastatic solid tumors who have failed standard treatment, or have no standard treatment, or are currently not eligible for standard treatment, or cannot tolerate standard treatment; 3. Provide tumor tissue samples for biomarker analysis if available; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 5. Life expectancy of greater than 3 months; 6. Adequate organ function: (1) Hematological system (no blood transfusion or hematopoietic stimulator therapy within 14 days): platelet count (PLT) >= 75 x 10^9/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; absolute white blood cell count >= 3.0 x 10^9/L; hemoglobin (Hb) >= 90 g/L; (2) Hepatic function: total bilirubin (TBIL) 45 ml/min by the Cockcroft-Gault formula; (4) Coagulation function: activated partial thrombin time (APTT) <= 1.5 x ULN, international standardized ratio (INR) <= 1.5 x ULN; 7. Female patients of childbearing potential (non-surgical sterilization and from menarche to 1 year postmenopause) must have a negative urine or serum pregnancy test within 72 hours prior to the first dose of the investigational drug. If the patient of childbearing potential must agree to abstain from sex or use a highly effective method of contraception from the time of signing the informed consent, until 6 months after the last dose of the trial drug; 8. Subjects must give informed consent to this study before the trial, and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, surgery and other anti-tumor treatments 4 weeks before the first use of the test drug or within 5 half-lives (whichever is shorter). Those who have used nitrosourea or mitomycin C within 6 weeks before the first use of the test drug; received oral fluorouracil chemotherapy or small molecule targeted drugs within 2 weeks or 5 half-lives before the first dose Whichever is applicable); within 2 weeks before the first use of the trial drug, accept the Chinese patent medicine with anti-tumor indications approved by NMPA and the Chinese Medicine with anti-tumor effect; 2. Used other unlisted investigational drug or device within 2 weeks prior to the first dose; 3. Had major organ surgery (excluding puncture biopsy) or significant trauma within 2 weeks prior to the study day1, or needed to undergo elective surgery during the study period; 4. Received systemic glucocorticoids (prednisone > 10 mg/day or equivalent drug) or other immunosuppressive therapy within 2 weeks prior to the first dose,Except for topical, ocular, intraarticular, intranasal, inhaled glucocorticoids, and short-term use of glucocorticoids for prophylactic treatment (e.g. to prevent contrast agent-induced allergic reactions); 5. Used immunomodulator, including but not limited to thymosin, interleukin-2, interferon, etc., within 2 weeks prior to the first dose; 6. Live attenuated vaccine administered within 4 weeks prior to study day; 7. Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation; 8. Adverse reactions from previous antitumor therapy have not yet resolved to CTCAE v5.0 grade 0 or 1 (except for alopecia, pigmentation, neurotoxicity, etc. resolved to grade 2 or below); 9. Patients of CNS metastases: (1) need local treatment (surgery, radiotherapy or others)(patients of no symptoms or otherwise deemed to need not local treatment); (2) use prednisone > 10 mg/day (or equivalent drug).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Tolerance; | — |
Countries
China
Contacts
Public ContactZhou Caicun
Shanghai Pulmonary Hospital
Outcome results
None listed