NCT05518526

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Soft Tissue Sarcoma
• Pulmonary Metastasis

Interventions

Type	Name	Description
DRUG	Liposomal Annamycin (L-Annamycin)	Study drug consists of L-Annamycin as a lyophilised powder in 50-mL single-use vials containing 45 mg of L-Annamycin must be reconstituted with 45 mL of 0.9% sodium chloride injection between 34 to 42℃, USP, and then diluted 1:1 with 0.9% sodium chloride injection between 34 to 42℃ in non-polyvinyl chloride IV bags before intravenous infusion. The dose of L-Annamycin will be intravenously applied during 2 hours infusion on D1, D8, and D15 of each 28-day cycle (up to Cycle 6th).

Timeline

• Start date: 2022-08-23
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2022-08-26
• Last updated: 2022-08-26

Locations

1 site across 1 country: Poland