NEW YORK – K36 Therapeutics said on Tuesday that it has treated the first multiple myeloma patient in its Phase I clinical trial of KTX-1001.
In the Phase I trial, Cambridge, Massachusetts-based K36 is evaluating the multiple myeloma SET domain (MMSET) inhibitor as a treatment for relapsed or refractory multiple myeloma patients whose cancers harbor the t(4;14) genetic translocation.
The trial, dubbed MMSET-001, will enroll roughly 60 patients who have received at least three prior lines of treatment. For the second part of the two-part trial, K36 will enroll patients who either have a t(4;14) genetic translocation, based on fluorescence in situ hybridization testing, or a GOF mutation in MMSET confirmed by local sequencing.
In 2021, K36 raised $30 million in a Series A financing round, which it planned to use for proof-of-concept studies for KTX-1001. Then, last year, the US Food and Drug Administration cleared K36's investigational new drug application to begin the Phase I trial for the drug.
"KTX-1001 has not only demonstrated encouraging preclinical activity and a favorable tolerance profile, but it also addresses unmet need for patients who have received other standard-of-care therapies available to patients suffering from multiple myeloma," K36 CEO Terry Connolly said in a statement. "We look forward to working with all our sites, investigators, and study teams to efficiently enroll our Phase I clinical trial."