A Phase I Study of STM 434 in Patients with Ovarian Cancer and Other Advanced Solid Tumors

Full Title

An Open-Label Multiple Ascending Dose Phase 1/1B Pharmacokinetic and Pharmacodynamic Study of STM 434, an Activin Type 2B Receptor Fc Fusion, Alone and in Combination with Liposomal Doxorubicin in Patients with Ovarian Cancer or Other Advanced Solid Tumors

Purpose

STM 434 is an investigational drug that blocks the action of activin A and similar proteins which are present in high amounts in some cancers and may lead to tumor growth. Laboratory studies suggest that blocking activin A and similar proteins may reduce tumor growth, muscle loss, and tumor-related weight loss.

In this study, researchers want to find the highest dose of STM 434 that can be given safely in patients with ovarian cancer and other advanced solid tumors that have already been treated with at least one therapy. STM 434 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have ovarian cancer or another advanced solid tumor that has come back or continued to grow despite at least one prior regimen of therapy.
  • At least 3-4 weeks must pass between the completion of prior therapies and entry into the study, and patients must recover from any serious side effects.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Hyman at 646-888-4544.

Protocol

14-132

Phase

I

Investigator

Co-Investigators

Locations