PTC596-LMS (Leiomyosarcoma)

What is the Purpose of this Study?

We are doing this study to find out if a study drug called unesbulin is a safe and effective option that can help people with a type of soft tissue sarcoma called leiomyosarcoma.

What is the Condition Being Studied?

Advanced Leiomyosarcoma

Who Can Participate in the Study?

Adults ages 18+ who are diagnosed with locally advanced leiomyosarcoma.

For more information on who can participate in this study please contact the study team at

Age Group

What is Involved?

If you choose to join this study, you will get a random assignment to 1 of 2 groups:
- One group will the study drug in combination with a standard drug called dacarbazine
- The other group will get a placebo (inactive substance that has no drug in it) in combination with dacarbazine

No matter to which group you are assigned, during the study you will:
- Have physical exams, electrocardiograms (ECG), and blood draws
- Have CT or MRI scans

You will visit our clinic for follow-up visits after you stop taking the study drugs, and we will keep in touch with you to see how you are feeling.

Study Details

Full Title
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma
Principal Investigator
Associate Professor in Medicine
Protocol Number
IRB: PRO00110891
NCT: NCT05269355
Phase II/III
Enrollment Status