Pomalidomide: Module 3 Standard of Care (background treatment)
Dexamethasone: Module 3 Standard of Care (background treatment)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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 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 with the IMWG Diagnostic Criteria;
* 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 summary of key criteria, other inclusion criteria details may apply
Key Exclusion Criteria:
* 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 monoclonal antibody therapy;
* 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 exclusion criteria details may apply
Primary outcome measure(s)
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only) — 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) — 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) — 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.
Trial sites (43)
Facility
City
Region
Status
Research Site
Duarte
California
Recruiting
Research Site
Irvine
California
Recruiting
Research Site
Atlanta
Georgia
Recruiting
Research Site
Boston
Massachusetts
Recruiting
Research Site
Ann Arbor
Michigan
Recruiting
Research Site
St Louis
Missouri
Withdrawn
Research Site
New York
New York
Recruiting
Research Site
Philadelphia
Pennsylvania
Recruiting
Research Site
Fairfax
Virginia
Recruiting
Research Site
Fitzroy
Australia
Recruiting
Research Site
Melbourne
Australia
Recruiting
Research Site
Nedlands
Australia
Recruiting
Research Site
Wollongong
Australia
Not Yet Recruiting
Research Site
Salvador
Brazil
Not Yet Recruiting
Research Site
São Paulo
Brazil
Not Yet Recruiting
Research Site
São Paulo
Brazil
Not Yet Recruiting
Research Site
Hamilton
Ontario
Recruiting
Research Site
Ottawa
Ontario
Recruiting
Research Site
Toronto
Ontario
Not Yet Recruiting
Research Site
Montreal
Quebec
Recruiting
Research Site
Nova Scotia
Canada
Not Yet Recruiting
Research Site
Beijing
China
Recruiting
Research Site
Changsha
China
Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Shenyang
China
Recruiting
Research Site
Lille
France
Recruiting
Research Site
Nantes
France
Recruiting
Research Site
Essen
Germany
Recruiting
Research Site
Freiburg im Breisgau
Germany
Withdrawn
Research Site
Hamburg
Germany
Recruiting
Research Site
Heidelberg
Germany
Not Yet Recruiting
Research Site
Lübeck
Germany
Recruiting
Research Site
Nuremberg
Germany
Recruiting
Research Site
Tübingen
Germany
Not Yet Recruiting
Research Site
Würzburg
Germany
Recruiting
Research Site
Kashiwa
Japan
Recruiting
Research Site
Nagoya
Japan
Recruiting
Research Site
Yamagata
Japan
Recruiting
Research Site
Badalona
Spain
Not Yet Recruiting
Research Site
Madrid
Spain
Recruiting
+ 3 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.