Phase I Study of Safety and Pharmacokinetics of RO7297089, an Anti-BCMA/CD16a Bispecific Antibody, in Patients with Relapsed, Refractory Multiple Myeloma

• DOI: 10.1007/s44228-022-00023-5
• Publication Date: 2023-01-19T11:19:05Z
• Authors: Torben Plesner; Simon J. Harrison; Hang Quach; Cindy Lee; Adam Bryant; Annette Vangsted; Jane Estell; Michel Delforge; Fritz Offner; Patrick Twomey; Voleak Choeurng; Junyi Li; Robert Hendricks; Shannon M. Ruppert; Teiko Sumiyoshi; Karen Miller; Eunpi Cho; Fredrik Schjesvold
• Keywords: Refractory (planetary science)

This phase 1 trial assessed the safety, pharmacokinetics, and preliminary antitumor activity of RO7297089, an anti-BCMA/CD16a bispecific antibody.RO7297089 was administered weekly by intravenous infusion to patients with relapsed/refractory multiple myeloma. The starting dose 60 mg in this dose-escalation study utilizing a modified continual reassessment method overdose control model.Overall, 27 were treated at doses between 1850 mg. maximally due excipients formulation that did not allow for higher be used. maximum tolerated reached. most common adverse events irrespective grade relationship drug anemia, infusion-related reaction, thrombocytopenia. Most treatment-related ≥ 3 toxicities ALT/AST increase reduced lymphocyte count. Pharmacokinetic studies suggested non-linear pharmacokinetics target-mediated disposition, trend approaching linear 1080 higher. Partial response observed two (7%), minimal stable disease 14 (52%).RO7297089 well up mg, efficacy data supported RO7297089 Combination other agents may further enhance its potential as innate immune cell engager myeloma.ClinicalTrials.gov: NCT04434469; Registered June 16, 2020; https://www.gov/ct2/show/NCT04434469 .