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news.Cleave Biosciences has started an open-label, dose escalation/dose expansion Phase I clinical trial of its lead drug candidate, CB-5083, for the treatment of patients with relapsed and refactory multiple myeloma.
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The trial is designed to assess the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of CB-5083 in multiple myeloma patients who have relapsed/refractory or refractory disease after receiving two or more lines of therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor.
The company will enroll around 60 patients in the trial at multiple US cancer centres that are part of the Multiple Myeloma Research Consortium.
CB-5083 is a potent, specific and orally bioavailable inhibitor of p97, a major enzyme through which several aspects of protein homeostasis can be controlled.
Cleave Biosciences chief executive officer Laura Shawver said patients with multiple myeloma whose disease is resistant to existing therapies have run out of options.
"We are eager to assess CB-5083 in this trial and to further understand which tumors are dependent on the p97 pathway for their growth and survival so we can focus our future clinical program on the patients most likely to benefit from this potential treatment," Shawver said.
The company said that CB-5083 has robust activity in multiple hematological models as well as in solid tumor xenograft models that are resistant to proteasome inhibitors.
The preclinical trials have showed significant promise for CB-5083 in solid tumors.
The company is currently planning to start a Phase I trial in solid tumors later in 2014.