TH-302 is a hypoxia-targeted drug where as Bortezomib is approved for the treatment of multiple myeloma, a hematologic cancer that develops in the bone marrow.
The primary objectives of the open label study are to evaluate the safety and tolerability of TH-302, to identify potential dose-limiting toxicities, and to determine the maximum tolerated dose (MTD) and a recommended Phase II dose.
The study will enroll up to 60 patients at the Dana-Farber Cancer Institute in Boston, Massachusetts.
The company plans to enroll patient into a separate dose escalation study investigating TH-302 in combination with bortezomib using the same dosing schedule, if the monotherapy is well tolerated in the dose escalation and expansion phases.
Threshold CEO Barry Selick said the company is working with the Dana-Farber Cancer Institute to investigate TH-302 as a monotherapy and in combination therapy in patients with multiple myeloma.