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Brief Title: AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
Official Title: A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Lmmunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Relapsed or Refractory Multiple Myeloma
Study ID: NCT06106945
Brief Summary: This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.
Detailed Description: This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM. This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents. The study includes dose escalation and dose expansion phases. This study will enroll subjects with RRMM who received at least 3 prior lines of treatment including at least one proteasome inhibitor (PI), one immunomodulator (IMiD), and an anti-CD38 antibody. Subjects will be administered AZD0305 intravenously.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Duarte, California, United States
Research Site, Irvine, California, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Saint Louis, Missouri, United States
Research Site, New York, New York, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Fairfax, Virginia, United States
Research Site, Melbourne, , Australia
Research Site, Perth, , Australia
Research Site, Hamilton, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Beijing, , China
Research Site, Freiburg, , Germany
Research Site, Hamburg, , Germany
Research Site, Lübeck, , Germany
Research Site, Nürnberg, , Germany
Research Site, Würzburg, , Germany
Research Site, Kashiwa, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Madrid, , Spain
Research Site, Pamplona, , Spain
Research Site, Salamanca, , Spain