Informing the Recommended Phase III Dose of Alnuctamab, a CD3 × BCMA T‐Cell Engager, Using Population Pharmacokinetics and Exposure–Response Analysis
Brian Kiesel,
Mayu Osawa,
Madhan Masilamani
et al.
Abstract:Alnuctamab, a B‐cell maturation antigen (BCMA)‐targeting T‐cell engager, has demonstrated encouraging antitumor activity in the phase I study CC‐93269‐MM‐001 treating patients with relapsed or refractory multiple myeloma. Identification of a recommended Phase III dose (RP3D) was a key objective, as such population pharmacokinetic (PopPK) and exposure–response analysis was critical. Intravenous (IV) alnuctamab was administered in fixed doses (0.15–10 mg) or in step‐up doses to a maximum 10‐mg target dose. Subcu… Show more
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