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Also known as AZD4512 monotherapy
AZD4512 · 2 trials · 2 indications
DLTs are dose-limiting toxicities as defined in the study protocol.
Assessed by the CTCAE criteria version 5.0
To evaluate the efficacy based on NCCN response criteria, measured by ORR (CR/CRh)
Assessed by the CTCAE criteria version 5.0
To identify the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in participants with R/R B-NHL
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
| Arm | Type | Description |
|---|---|---|
| Module 1 Dose Escalation | EXPERIMENTAL | Module 1 will evaluate escalating doses of AZD4512 as monotherapy to determine the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in Module 2 (dose optimization), in participants with relapsed/refractory (R/R) Philadelphia chromosome positive (Ph\[+\]) and negative (Ph\[-\]) B-ALL, R/R as defined by National Comprehensive Cancer Network (NCCN) guidelines. |
| Module 2 Dose Optimization | EXPERIMENTAL | Module 2 will randomize participants with R/R (as defined by NCCN guidelines) Ph(-) BALL only across 2 to 3 dose levels identified in Module 1 to receive AZD4512 monotherapy for further exploration of the doses. The aim of Module 2 is to identify the recommended Phase 2 dose (RP2D) of AZD4512 monotherapy, evaluate the efficacy and further define the safety profile of AZD4512. |
| Module 1: AZD4512 Monotherapy dose escalation + backfill | EXPERIMENTAL | In Mod 1, the efficacy and safety of AZD4512 will be evaluated in R/R B-NHL. Module 1 will consist of both dose escalation and Pharmacodynamic/safety backfills which may be used to support MTD and/or Optimal biological dose (OBD) |
| Name | Type | Description |
|---|---|---|
| AZD4512 monotherapy | COMBINATION_PRODUCT | Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22 |
| AZD4512 | DRUG | AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion |
Inclusion Criteria: * 1\. Age: * 16 years old in Module 1 (US only: ≥18year) * 12 years old in Module 2 2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022). * All Participants must have relapsed or refractory B-ALL ('relapsed' d...
AZD4512 is an investigational small molecule being developed by AstraZeneca PLC (ticker AZN) for B-cell blood cancers. It is a biomarker-selected therapy being studied in B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma. It is currently in Phase 1 clinical development and has not been approved for any indication.
AZD4512 is being studied for the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma. It is an investigational agent in Phase 1 testing, so it is not yet available as a treatment outside of clinical trials. Enrollment is biomarker-selected.
AZD4512 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is running the clinical program for the drug across multiple countries, including the United States, United Kingdom, Japan, China, Australia, Canada, South Korea, Taiwan, Italy, and Spain.
AZD4512 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. Two Phase 1 studies are currently recruiting participants, one in B-cell Non-Hodgkin Lymphoma and one in B-cell Acute Lymphoblastic Leukemia.
AZD4512 is being evaluated in two recruiting Phase 1 trials. NCT07123454 studies AZD4512 monotherapy or in combination with anticancer agents in relapsed or refractory B-cell Non-Hodgkin Lymphoma, with 91 participants. NCT07109219 studies AZD4512 monotherapy or in combination with anticancer agents in Acute Lymphoblastic Leukemia, with 83 participants.
Yes, AZD4512 monotherapy refers to the same investigational drug, AZD4512, when given as a single agent rather than in combination with other anticancer agents. The ongoing Phase 1 trials are designed to test AZD4512 both as monotherapy and in combination with other anticancer agents.