late-stage solid tumor
Conditions
Interventions
Experimental group:The initial dosage of legobex for injection is set at 20mg/m^2, with the preset maximum incremental dose being 200mg/m^2. Five dose groups are tentatively planned. The overall desig
Sponsors
The East Hospital Affiliated to Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old (inclusive of both ends), gender not restricted. 2. Patients with advanced malignant solid tumors confirmed by histology or cytology (priority for lung cancer and other types in the dose expansion stage), who have failed standard treatment, or have no standard treatment options, or whose current standard treatment is not applicable. 3. According to RECIST 1.1 version, at least one evaluable tumor lesion. 4. ECOG physical performance score: 0 - 1. 5. Expected survival time: more than 3 months. 6. Adequate organ function: (1) Hematological system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days) 1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L 2) Platelets (PLT) >= 75 × 10^9/L 3) Hemoglobin (Hb) >= 90 g/L (2) Liver function 1) Total bilirubin (TBIL) 50 ml/min (calculated according to the Cockcroft-Gault formula) (4) Coagulation function 1) Activated partial thromboplastin time (APTT) = 55% (6) Liver function classification for HCC patients 1) Child-Pugh score <= 7 points 7. Qualified patients with reproductive capacity (both male and female) must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence) with their partners during the trial period and for at least 3 months after the last medication; for female patients of childbearing age, the blood or urine pregnancy test within 7 days before enrollment must be negative. 8. Participants must be informed and consent to this study before the trial, and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Within 4 weeks prior to the first administration, the subject had received chemotherapy, radiotherapy, targeted therapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments. Exclusions include the following: (1) Nitrosoureas or mitomycin C were used within 6 weeks prior to the first administration of the study drug; (2) Oral fluorouracil and small molecule targeted drugs were used within 2 weeks of the first administration of the study drug or within 5 half-lives of the drug (whichever is longer); (3) Traditional Chinese medicine with anti-tumor indications was used within 2 weeks of the first administration of the study drug; (4) Trastuzumab was used within 6 months of the first administration of the study drug. 2. The subject had previously received multiple doxorubicin or other anthracycline drugs. 3. Within 4 weeks prior to the first administration, the subject had received other off-label clinical research drugs or treatments. 4. Within 4 weeks prior to the first administration, the subject had undergone major organ surgery (excluding biopsy) or had suffered significant trauma, or required elective surgery during the trial. 5. Within 14 days prior to the first administration, the subject had received systemic glucocorticoids (prednisone > 10mg/day or equivalent doses of similar drugs) or other immunosuppressant treatments; Exclusions include: local, ocular, joint cavity, nasal, and inhalation glucocorticoid treatments; short-term use of glucocorticoids for prophylactic treatment (such as for preventing contrast agent allergy). 6. The adverse reactions from previous anti-tumor treatments have not yet recovered to a CTCAE 5.0 grade evaluation 10^3 copies/ml or 200IU/ml): hepatitis C infection (HCV-RNA above the detection limit): Permitted preventive antiviral treatment except interferon. For HCC patients, hepatitis B virus titer > 10^4 copies/ml or 2000IU/ml are excluded. 10. Have immune deficiency disease history, including positive HIV antibody test. 11. Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) Severe cardiac rhythm or conduction abnormalities, such as clinically intervened ventricular arrhythmias, II-III degree atrioventricular block, etc.; (2) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular events within 6 months of the first administration; (3) American Heart Association (NYHA) cardiac function classification = II grade or left ventricular ejection fraction (LVEF) < 50%, or other factors judged by the investigator to have high risk of structural heart disease; (4) Uncontrolled hypertension; (5) Any factor that increases the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT synd
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD/RP2D;Incidence & Number of DLTs;Incidence & Frequency of AEs and SAEs (NCI CTCAE 5.0); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameters: including but not limited to AUC, CL, Cmin, Cmax, T?/?, et al.;Efficacy: Objective Response Rate (ORR), Disease Control Rate (DCR) and Progression-Free Survival (PFS) assessed per RECIST Version 1.1 criteria.;Percentage of CD3+, CD4+ and CD8+ T-cell subsets in peripheral blood lymphocytes; Severity of cancer pain (assessed by the Numerical Rating Scale [NRS]); Alpha-fetoprotein (AFP, for HCC patients only); Beta C-terminal telopeptide of type I collagen (ß-CTX) (for patients with tumor bone metastasis only); | — |
Countries
China
Contacts
Public ContactJin Li
The East Hospital Affiliated to Tongji University
Outcome results
None listed