AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD0305: AZD0305 Investigational product
Elranatamab: Module 2 Investigational product
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
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.
More AstraZeneca trials in Spain
Other trials for the same condition
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.
View NCT06106945 on ClinicalTrials.gov ↗ ← All trials in Spain