Clinical Trials | A Phase 1 Study of Peposertib (M3814) and Low-Dose Liposomal Doxorubicin in Patients with Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have metastatic leiomyosarcoma and other soft tissue sarcomas. The purpose of this study is to see what the highest dose of peposertib (M3814) and liposomal doxorubicin can be safely and tolerably taken in soft tissue sarcoma that has spread. There are two parts in this study, a dose escalation part (dose finding) and a dose expansion part (where the established dose is tested further). Your doctor will tell you which part you are in. • In the dose escalation part of this study, different people will get different doses of both study drugs, peposertib (M3814) and liposomal doxorubicin. • In the dose expansion part of this study, the highest dose with manageable side effects will be given to 12 more people. This will help study doctors better understand the side effects that may happen with this drug You will get oral tablets of peposertib (M3814) twice daily, every day. You will get liposomal doxorubicin through a vein in your arm on the first day of each cycle. Each cycle lasts 28 days. This study has no maximum number of cycles. You will receive the study drugs until your disease progresses or you decide to withdraw consent. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT05711615 [email protected]