PHASE I DOSE ESCALATION STUDY OF 3-WEEKLY INTRAVENOUS DPPG2-TSL-DOX COMBINED WITH REGIONAL HYPERTHERMIA IN LOCALLY ADVANCED OR METASTATIC SOFT TISSUE SARCOMA
This phase 1 study aims to explore a new therapeutic approach for advanced soft tissue sarcoma (STS) by investigating the safety, tolerability, and maximum tolerable dose (MTD) of DPPG2-TSL-DOX combined with regional hyperthermia (RHT) in patients who have been pre-treated with doxorubicin (DOX). DPPG2-TSL-DOX is a novel formulation of DOX encapsulated in DPPG2-containing temperature sensitive liposomes. Regional hyperthermia (RHT) with a tumor target temperature of ≥106.7 to ≤111.2 degrees Fahrenheit triggers a localized release of DOX into the tumor.