Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06106945 | AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma | PHASE1 | RECRUITING | 226 | — | — | Dec 5, 2023 | Aug 16, 2027 | Jun 2, 2026 | 40 | United States, Australia +6 |
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...