drugset / Trial / NCT06173726

Investigator-initiated Phase I Exploratory Clinical Study of the Safety, Tolerability, and Efficacy of BST02 Injection in the Treatment of Locally Advanced/Metastatic Liver Cancer

NCT06173726 ↗

Phase 0 Not yet recruiting 6 enrolled BioSyngen Pte Ltd Shenzhen Second People's Hospital · collab
NaSingle-groupOpen-labelTreatment

Summary

This is an open, single-arm, investigator-initiated Phase I clinical trial to evaluate the safety, tolerability, and initial efficacy of BST02 injection in patients with locally advanced / metastatic liver cancer. This study includes a dose escalation study and a dose extension study, which will observe the effects of different IL-2 injection doses on the safety and efficacy of BST02. After signing the informed consent, the subjects will roughly go through two periods: the main study period and the long-term follow-up period. The main study period includes screening period, treatment and safety observation period, and follow-up period

Timeline

Start
2023-12-05
Primary completion
2026-12-05
Completion
2026-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject BST02 Cell therapy — —

Indications