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AZD0305 for Multiple Myeloma

Phase 1 & 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of azd0305 to death (approximately 2 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests AZD0305, a new drug, in patients with a type of cancer that hasn't responded to multiple treatments. The drug is given through an IV, and researchers will study its effects on the body and the cancer.

Who is the study for?
This trial is for people with Multiple Myeloma who've had at least three prior treatments, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody. They should be relatively active (ECOG 0-1), expected to live at least six more months, and have certain levels of M protein or free light chains indicating disease presence.
What is being tested?
The study tests AZD0305's safety and effectiveness in those whose multiple myeloma has returned or didn't respond to treatment. It's early-stage research involving multiple centers where participants openly receive the drug while researchers track its effects on their bodies and cancer.
What are the potential side effects?
Specific side effects for AZD0305 aren't listed but may include typical reactions seen in cancer therapies such as nausea, fatigue, blood count changes, organ inflammation, allergic reactions to the drug components or increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It seems there might be a mistake, as the term "Key" on its own is not a clear clinical trial exclusion criterion. If you could provide more information or context about this, I would be happy to help you further.
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I am fully active or can carry out light work.
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I have had 3 treatments including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of azd0305 to death (approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of azd0305 to death (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
Secondary study objectives
Phase Ia: Duration of response (DoR)
Phase Ia: Immunogenicity of AZD0305
Phase Ia: Objective Response Rate (ORR)
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AZD0305 monotherapyExperimental Treatment1 Intervention
Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels.

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,122,673 Total Patients Enrolled
8 Trials studying Multiple Myeloma
5,205 Patients Enrolled for Multiple Myeloma
~40 spots leftby Nov 2025
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