A Phase I/II Clinical Study of the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in the Treatment of Malignant Pleural and Abdominal Effusions
This is a Phase I/II, open, first-in-human (FIH) study of Transebacillus in Patients with malignant pleural and abdominal effusions. It consists of Phase Ia to determine the Maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) of Transebacillus, and Phase Ib/II to explore and confirm the efficacy, safety and Tolerability.
• Voluntarily participate, sign the informed consent, and good compliance, able to cooperate with the diagnosis and treatment and follow-up;
• Age ≥18 years old (inclusive), male and female are not limited;
• Malignant solid tumors other than primary hepatocellular carcinoma confirmed by pathological histological or cytological examination;
• Malignant thoracic/abdominal effusion patients who have failed at least one standard antitumor systemic therapy, are not suitable for standard systemic therapy, or have no standard systemic therapy. The pleural/abdominal effusion needs to be confirmed pathologically (malignant cells found in the cytosol or pathological changes of malignancy observed in the pleural/peritoneal biopsy tissue) or clinically diagnosed as malignant pleural/abdominal effusion;
• A pleural/peritoneal effusion of intermediate or greater volume confirmed by ultrasound, which in clinical judgment requires localized treatment of the pleural/ peritoneal effusion; definition of intermediate or greater volume: maximum depth of pleural effusion ≥ 3 cm by ultrasound in sitting position; or maximum depth of abdominal effusion ≥ 4 cm by ultrasound in lying position;
• KPS score ≥ 60;
• Expected survival ≥ 3 months;
• Major organ function is essentially normal and laboratory tests;
• Screening female subjects of childbearing potential with a negative serum pregnancy test; female/male subjects of childbearing potential must be willing to use a reliable method of contraception throughout the study period (i.e., from the time of signed informed consent to 90 days after the last dose of study medication), including, but not limited to, abstinence, a male partner who has undergone a vasectomy, female sterilization, an effective intrauterine device, and effective contraceptives.
• Patients are willing to participate in the study, sign an informed consent form, and have good compliance.