AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
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- Full 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
- Myeloma stage or condition:
- Multiple Myeloma
- Study phase:
- Phase 1/Phase 2
- Summary/Purpose:
- 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.
- Treatments:
- Drug : AZD0305
AZD0305
- Study Arms:
- Experimental : AZD0305 monotherapy
Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels.
- Study Type:
- Interventional
- Study Design:
- Allocation: N/A
- Intervention Model: Sequential Assignment
- Intervention Model Description: This protocol has a modular design, with the potential for future treatment arms, study parts, or modules to be added via protocol amendments. Module 1 will include Phase Ia (Dose escalation), and Phase Ib (Dose expansion/optimization).
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Recruitment status:
- Recruiting
- Eligibility criteria:
-
ipal Inclusion Criteria:
- Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
- Eastern Cooperative Oncology group (ECOG) performance status of ≤ 2.
- Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria.
- Participants must have one or more of the following measurable disease criteria: 1. Serum M-protein level ≥ 0.5 g/dL. 2. Urine M-protein level ≥ 200 mg/24h. 3. Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP.
- Participants must have received at least 3 prior lines of treatment which include a proteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and an anti-CD38 antibody (e.g., daratumumab). Principal
- Participants exhibiting clinical signs of central nervous system involvement of MM.
- Participants with known COPD, or previous history of ILD.
- Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification.
- Participants who have severe cardiovascular disease which is not adequately controlled.
- Participants who have a history of immunodeficiency disease.
- Participants with peripheral neuropathy ≥ Grade 2.
- Primary refractory MM.
- Participants who have previously received anti-GPRC5D or MMAE-containing treatment.
- Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention.
- Locations / Centres:
-
Research Site, Hamilton, Ontario – Not yet recruiting
Research Site, Montreal, Quebec – Not yet recruiting
- Contacts:
- Name: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
- Publications:
- ???
- First posted:
- 2023-10-30
- Actual start date:
- December 5, 2023
- Last updated:
- 2024-04-29
- Estimated enrollment:
- 84
- Estimated completion date:
- 2025-11-11
- Estimated primary completion date:
- 2025-11-11
- Condition:
- Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-N/A
- Accepts healthy volunteers:
- No
- Listed location countries:
- Australia
- Canada
- China
- Germany
- Japan
- Spain
- United States
- NCT number:
- NCT06106945
- Other study ID numbers:
- D7230C00001
- Has Data monitoring committee:
- No
- U.S. FDA-regulated product:
- Yes
- IPD Sharing Statement :
- ???
- Responsible party:
-
Sponsor
- Study sponsor:
- lead_sponsor
AstraZeneca
Industry
- Collaborators:
- ???
- Investigators:
- Not available
- Protocol Registration and Results System:
- ???
- Verification date:
- 2024-04-01