Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0305 · 1 trial · 1 indication
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
Number of patients with adverse events and serious adverse events by system organ class and preferred term
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.
| Arm | Type | Description |
|---|---|---|
| AZD0305 monotherapy | EXPERIMENTAL | Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be administered at specified dose levels. |
| AZD0305 + Elranatamab | EXPERIMENTAL | Module2: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with elranatamab, following the module-specific dosing. |
| AZD0305 + Pomalidomide and Dexamethasone | EXPERIMENTAL | Module3: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with pomalidomide and dexamethasone, following the module-specific dosing. |
| Name | Type | Description |
|---|---|---|
| AZD0305 | DRUG | AZD0305 Investigational product |
| Elranatamab | DRUG | Module 2 Investigational product |
| Pomalidomide | DRUG | Module 3 Standard of Care (background treatment) |
| Dexamethasone | DRUG | Module 3 Standard of Care (background treatment) |
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...
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AZD0305 is an investigational small molecule being studied for the treatment of multiple myeloma. It is currently in Phase 1 clinical development as a monotherapy or in combination with other anticancer agents for participants with this blood cancer. The drug is not yet approved and remains under investigation.
AZD0305 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with multiple myeloma.
AZD0305 is currently in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and preliminary activity in participants with multiple myeloma. As an investigational agent, it has not yet received regulatory approval and is still undergoing clinical evaluation.
AZD0305 is being evaluated in a Phase 1 clinical trial registered as NCT06106945. This study is recruiting participants with multiple myeloma and is being conducted across multiple countries, including the United States, Australia, Brazil, Canada, China, France, Germany, Japan, and Spain. The trial aims to enroll 226 participants.
AZD0305 is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in the available information, so its precise mechanism of action in treating multiple myeloma is not detailed. The drug is being investigated for its potential to combat this cancer when used alone or with other treatments.