Mundipharma EDO Begins Phase 1/2 Trial of Tinostamustine in Triple Negative Breast Cancer, Other Solid Tumors

Mundipharma EDO Begins Phase 1/2 Trial of Tinostamustine in Triple Negative Breast Cancer, Other Solid Tumors
Mundipharma EDO GmbH has initiated a Phase 1/2 clinical trial of tinostamustine (EDO-S101) in patients with advanced triple negative breast cancer (TNBC), ovarian cancer (OC), and other solid tumors. The study will be conducted in two parts. The first part of the study will focus on determining the safety, tolerability, maximum dose, and optimal dosing schedule of tinostamustine as primary objectives. The drug will be evaluated as a single agent in patients with solid tumors that have progressed after at least one line of therapy and where there is no other therapy available. This part of the trial will also determine how the drug behaves in the body, and how gene expression changes in tumors that respond to tinostamustine. The second part of the study will evaluate toxicity and response rates in selected relapsed/refractory solid tumors, primarily in triple negative breast cancer, ovarian cancer, small cell lung cancer (SCLC), and a few others. The primary goals will be assessing the objective response rate (ORR) and clinical benefit rate (CBR). It will also determine the drug's safety, progression-free survival, overall survival, and duration of response. The study will be led by researchers at Stanford University, Cedars Sinai Medical Center in Los Angeles, and The Mayo Clinic in Scottsdale, Arizona. "Following the initial Phase 1 study in hematological malignancies, I am delighted that EDO is now embarking on a further clinical trial in solid tumors,” Thomas
Subscribe or to access all post and page content.