liposomal topotecan (FF-10850)

P1, N=96, Recruiting, Fujifilm Pharmaceuticals U.S.A., Inc. | Trial primary completion date: Mar 2025 --> Dec 2025

P1, N=96, Recruiting, Fujifilm Pharmaceuticals U.S.A., Inc. | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Mar 2025

P1, N=96, Recruiting, Fujifilm Pharmaceuticals U.S.A., Inc. | Trial primary completion date: Jul 2023 --> Jul 2024

Topotecan (TPT) and capsaicin were used for the treatment of solid tumors...The HA-pSLPs formulation has shown remarkable tumor regression as compared to PpSLPs, pSLPs, and free drug combinations. These results demonstrated that TPT- and CAP-loaded HA-pSLPs offer a potential platform for targeted drug delivery to solid tumors.

Although topotecan is also approved in combination with cisplatin for cervical cancer, reductions of dose and administration frequency are required due to safety issues. FF-10850 demonstrated favorable efficacy and safety in combination with carboplatin, olaparib or anti-PD-1 antibody, likely related to preferential tumor drug exposure. The combination of FF-10850 with anti-PD-1 antibody efficiently established tumor-specific immunity and long-lasting tumor suppression. Collectively, these observations strongly support further investigations of FF-10850 and improved efficacy in combination with various anti-cancer agents.