drugset / Trial / NCT07397819
Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is a prospective, multi-cohort Phase Ib/II clinical trial, consisting of two stages as follows: 1. Phase Ib Dose-Escalation Stage To explore the dose-limiting toxicities (DLT) of intraperitoneally administered liposomal irinotecan in patients with malignant peritoneal effusion who have failed prior standard therapy, and to estimate the maximum tolerated dose (MTD) of the investigational agent. 2. Phase II Expansion Stage To evaluate the efficacy and safety of liposomal irinotecan as monotherapy or in combination with recombinant modified human tumor necrosis factor or bevacizumab, in the treatment of malignant peritoneal effusion in patients who have failed prior standard therapy.
Timeline
- Start
- 2025-11-28
- Primary completion
- 2028-06-30
- Completion
- 2029-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 100 mg | Other |
| Subject | Irinotecan | Small molecule | 20 mg | Other |
| Subject | Irinotecan | Small molecule | 30 mg | Other |
| Subject | Irinotecan | Small molecule | 40 mg | Other |
| Subject | rmhTNF-NC | Protein / enzyme biologic | 300 iu | Other |