The trial (NCT04671251) intends to enroll up to 30 adult patients who received prior treatment with a proteasome inhibitor, an immunomodulatory agent, and a CD38 inhibitor. Recruitment is ongoing at four U.S. sites. Initial data is expected in the next couple of months, the company announced.
Despite the approval and availability of new agents for treating multiple myeloma, patients continue to experience recurrent relapses, and the disease remains incurable for most patients. Overall, only 50% of those patients live five or more years past diagnosis.
Cerecor, a biopharmaceutical company focused on treatments for rare and orphan diseases, is developing CERC-007 for people with relapsed or refractory multiple myeloma.
“The approximately 50% mortality rate at five years reinforces the need for novel and targeted therapies, such as CERC-007, as another treatment option,” said Wilkins.
CERC-007 (formerly known as AEVI-007) is a human monoclonal antibody designed to target interleukin 18 (IL-18), a signaling molecule that helps myeloma cells hide from the immune system, leading to increased disease progression and worse survival rates.
“Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma,” said Wilkins.
The multicenter, open-label Phase 1b trial is enrolling patients who received multiple lines of treatment and for whom no additional regimens are known to provide clinical benefit.
It is designed to determine the safety, pharmacokinetics (the movement of a drug through and out of the body) and pharmacodynamics (the effects of a drug on the body) of CERC-007.
Participants, ages 18 and older, will be treated with ascending doses of CERC-007, given in a single injection, and followed for about nine months. The primary goal of the study is to identify the recommended dose of CERC-007 for Phase 2 studies.
Preliminary efficacy measures include the proportion of patients who respond to treatment, time to response and duration of responses, the time patients live without disease worsening, and whether patients develop antibodies that affect treatment efficacy.
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