A phase II trial with a safety lead-in to evaluate the addition of APX005M, a CD40agonistic monoclonal antibody, to standard-of-care doxorubicin for the treatment of advancedsarcoma

Contact:

NCT Number:

Protocol:

AAAS0095

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II

The purpose of this study is to evaluate the effectiveness of a new investigational drug, APX005M, used in combination with the standard (or “usual”) treatment for these types of sarcoma. The standard treatment is doxorubicin (a chemotherapy) and olaratumab (a “targeted” drug which works against a protein that makes sarcomas grow). The investigators believe that doxorubicin and olaratumab, the standard treatment, may work better when combined with APX005M. The purpose of this clinical trial is to evaluate the safety of doxorubicin, olaratumab and APX005M when used together, and to see if this study treatment is effective for patients with Dedifferentiated liposarcoma, Leiomyosarcoma, and Undifferentiated pleomorphic sarcoma

Are you Eligible? (Inclusion Criteria)

  • Are you 18 years of age or older?
  • Have you been diagnosed with undifferentiated pleomorphic sarcoma,
  • dedifferentiated liposarcoma or leiomyosarcoma?
  • Do you have no history of active autoimmune disease?
  • Do you have measurable disease?
  • Do you have adequate cardiac and bone marrow function?

Specialty Area(s)

Soft Tissue Sarcoma, Immunotherapy

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032