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New treatment option for Multiple Myeloma
Official title AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
ClinicalTrials.gov ID: NCT06106945
What this study is testing
What is AZD0305?
AZD0305 is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;
- Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should...
- Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as...
You likely can't join if
- Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or...
- Participants exhibiting clinical signs of central nervous system involvement of MM;
- Participants with known COPD, or previous history of ILD/pneumonitis;
- 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;
See the full eligibility 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 performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;
- 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...
- Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;
- Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module;
- Participants must have received at least 3 prior lines of treatment in module 1, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy The above is a...
- Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);
- Participants exhibiting clinical signs of central nervous system involvement of MM;
- Participants with known COPD, or previous history of ILD/pneumonitis;
- 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;
- Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply;
- Participants with previous history of active JC virus infection resulting in PML;
- Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior...
- Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration The above is a summary of key criteria, other...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Fairfax, Virginia, United States
- Fitzroy, Australia
- Melbourne, Australia
- Nedlands, Australia
- Wollongong, Australia
- Salvador, Brazil
- São Paulo, Brazil
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Nova Scotia, Canada
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.