NCT06106945 · AstraZeneca
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
What this study is about
This is a Phase I/II, modular, where both patients and doctors know the treatment given, conducted at multiple hospitals, gradually increasing doses, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, how the drug affects the body, and preliminary effectiveness of AZD0305 in participants with RRMM.
View original scientific 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.
Interventions
DRUG
AZD0305
AZD0305 Investigational product
DRUG
Elranatamab
Module 2 Investigational product
DRUG
Pomalidomide
Module 3 Standard of Care (background treatment)
DRUG
Dexamethasone
Module 3 Standard of Care (background treatment)
Primary outcome measures
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
Time frame: From first dose of AZD0305 until the end of Cycle 1. Cycle 1 (the DLT assessment period is 21 days for Module 1 Group A and 28 days for Module 1 Group B, Module 2, and Module 3)
A DLT is any toxicity occuring from the first dose of AZD0305 up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes, any death not clearly due to the underlying disease or extraneous causes, pre-defined haematological and non-haematological toxicities
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From time of Informed consent to 30 days post end of treatment
Number of patients with adverse events and serious adverse events by system organ class and preferred term
Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3)
Time frame: From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days)
Number and percentage of participants with dose modifications, dose delays, and permanent discontinuations due to adverse events (for AZD0305 and combination agent\[s\], as applicable), per protocol-defined dose modification rules.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 i
Where
- Duarte, California
- Irvine, California
- Atlanta, Georgia
- Boston, Massachusetts
- Ann Arbor, Michigan
- St Louis, Missouri
- New York, New York
- Philadelphia, Pennsylvania
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations