Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD0486 IV
AZD0486 · 2 trials · 5 indications
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.
A DLT is defined as a TEAE that is not unequivocally due to the subject's underlying malignancy or other extraneous cause. DLT evaluable subjects are defined as those subjects who receive either the target dose of AZD0486 or priming dose(s) in any step-up dose schedule and are assessed for toxicities for the 28-day evaluation period. The NCI-CTCAE version 5.0 will be used (except for CRS and NT). A DLT will be evaluated as Non-hematologic, Hematologic, Cytokine Release Syndrome (CRS), or neurotoxicity.
The incidence, timing, seriousness, and relationship to study treatment of adverse events will be evaluated.
The maximum observed serum concentration on a concentration time curve.
Area under the serum concentration-time curve from time zero to time of last measurable concentration.
Terminal half-life (t1/2,) will be determined after infusion in Cycle 1 using non-compartmental methods.
| 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. |
| AZD0486 Monotherapy Dose Escalation in Subjects with B-NHL | EXPERIMENTAL | AZD0486 monotherapy will be administered intravenously on day 1 and 15 of 28 day cycles for a maximum of 2 years or until discontinuation criteria are met. Depending on cohort, subjects may receive priming or step-up dosing administered weekly during cycle 1 before reaching the target dose. Additional cohorts may be opened where subjects receive weekly dosing during Cycles 1-2. While on study, subjects will be monitored for safety and efficacy with periodic disease assessment with PET/CT. If subject achieves two consecutive CRs after completing C6, then they may be eligible for monthly dosing |
| 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 |
| AZD0486 IV | DRUG | AZD0486 is a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells leading to T cell-mediated cytotoxicity of malignant B cells |
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...
AZD0486 is an investigational oncology therapy being studied for the treatment of B-cell non-Hodgkin lymphoma and large B-cell lymphoma. It is currently in clinical development for these blood cancers, which include subtypes such as diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma.
AZD0486 is being developed by AstraZeneca PLC, a global biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with certain types of lymphoma.
AZD0486 is in Phase 1 clinical development. One active Phase 1 study is evaluating the drug in patients with B-cell non-Hodgkin lymphoma, and a separate Phase 3 trial is also listed as recruiting for large B-cell lymphoma, indicating the program is advancing through clinical testing.
AZD0486 is being studied in two clinical trials. NCT04594642 is a Phase 1 study in B-cell non-Hodgkin lymphoma with 226 participants, active but not recruiting. NCT07215585 is a Phase 3 trial in large B-cell lymphoma for elderly or unfit patients, currently recruiting 420 participants across multiple countries.
Yes, AZD0486 IV is another name for AZD0486. The intravenous formulation is referenced in clinical trial documentation, and both names refer to the same investigational drug being developed by AstraZeneca for the treatment of B-cell lymphomas.