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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07215585 | AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL | PHASE3 | RECRUITING | 420 | — | — | Nov 11, 2025 | Jul 28, 2033 | May 22, 2026 | 64 | Australia, Belgium +9 |
Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the Safety Run-In part
Progression-free Surival (PFS), based on Lugano 2014 Response Criteria.
| Arm | Type | Description |
|---|---|---|
| Phase III Arm A: R-mini-CHOP and AZD0486 | EXPERIMENTAL | 2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP3D. |
| Phase III Arm B: R-mini-CHOP | ACTIVE_COMPARATOR | 6 cycles of R-mini-CHOP per SoC regimen. |
| Safety Run in: R-mini-CHOP and AZD0486 | EXPERIMENTAL | 2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP2D. |
| Name | Type | Description |
|---|---|---|
| AZD0486 | DRUG | Bispecific monoclonal IgG4 antibody |
| R-mini-CHOP | DRUG | Intravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2 |
Inclusion criteria: * Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment; * Histologically confirmed diagnosis of previously untreated LBCL as p...