Phase 1b/2 Study of Liposomal Annamycin (L-Annamycin) in Subjects With Previously Treated Soft-Tissue Sarcomas (STS) With Pulmonary Metastases — ANNA-SARC  

Soft Tissue Sarcoma Clinical Trial

Official title: Phase 1b/2 Study of Liposomal Annamycin (L-Annamycin) in Subjects With Previously Treated Soft-Tissue Sarcomas (STS) With Pulmonary Metastases (ANNA-SARC)

Status Recruiting

Clinical Trial Summary

This study is a multi-centre, open-label, single-arm, 3+3 Phase 1b/ and Phase II. Phase 1b is aimed to determine the maximum-tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) based on safety reporting. The RP2D is a multifactorial endpoint that considers toxicity as well as additional determinants (e.g. efficacy, pharmacodynamics) to define the optimal Phase 2 dose. Phase 2 will explore the efficacy of L-Annamycin at RP2D for treating soft tissue sarcomas (STS) subjects with lung metastases, for which chemotherapy is considered appropriate.

Clinical Trial Description

The project aims to conduct a Phase 1b/2 clinical trial using liposomal Annamycin (L-Annamycin) in subjects diagnosed with soft tissue sarcoma (STS) in the stage of unresectable pulmonary dissemination after the failure of at least one line of prior systemic treatment. The most common localisation of metastatic lesions in STS is the lungs (refer to this as a "sanctuary site" for STS). Furthermore, although the most common dosing regimen for other anthracyclines (typically, doxorubicin) in the treatment of STS has historically been once every three weeks, preclinical testing of L-Annamycin suggests that weekly dosing of L-Annamycin may be more beneficial, as well as it seems to be both safer and more effective than alternative schedules. Therefore, this Phase Ib/II clinical trial will test the hypothesis that L-Annamycin administration in monotherapy in the weekly schedule (D1, D8, D15 in 28-day cycles) is safe and has the pharmacodynamic (PD) potential to restore and enhance tumour responses in anthracycline-pre-treated subjects with advanced and/or metastatic STS until disease progression, unacceptable toxicities, or subject consent withdrawal. ;

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm Metastasis
• Pulmonary Metastasis
• Sarcoma
• Soft Tissue Sarcoma

• NCT number: NCT05518526
• Study type: Interventional
• Source: Maria Sklodowska-Curie National Research Institute of Oncology
• Contact: Piotr Rutkowski, MD PhD Professor
• Phone: +48225462184
• Email: piotr.rutkowski@pib-nio.pl
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 23, 2022
• Completion date: August 2025