Study identifier:D7230C00001
ClinicalTrials.gov identifier:NCT06106945
EudraCT identifier:N/A
CTIS identifier:2023-508590-89-00
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
Multiple Myeloma
Phase 1/2
No
AZD0305
All
99
Interventional
18 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
-
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 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.
Location
Status
Location
Duarte, CA, United States, 91010
Status
Recruiting
Location
Irvine, CA, United States, 92618
Status
Recruiting
Location
Saint Louis, MO, United States, 63110
Status
Recruiting
Location
Melbourne, Australia, 3000
Status
Recruiting
Location
Nedlands, Australia, 6009
Status
Recruiting
Location
Montreal, Québec, Canada, H4A 3J1
Status
Recruiting
Location
Hamilton, ON, Canada, L8V 5C2
Status
Recruiting
Location
Fairfax, VA, United States, 22031
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: AZD0305 monotherapy Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels. | - |
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