NCT04887298

Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) with Pulmonary Metastases

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Moleculin Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate.

Conditions

• Sarcoma,Soft Tissue
• Pulmonary Metastasis

Interventions

Type	Name	Description
DRUG	Liposomal Annamycin (L-Annamycin)	2-hour intravenous (IV) infusion of L-Annamycin on Day 1 followed by 20 days off of study drug (i.e., 1 treatment cycle= 21 days)

Timeline

• Start date: 2021-06-05
• Primary completion: 2022-09-29
• Completion: 2024-08-06
• First posted: 2021-05-14
• Last updated: 2024-10-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study