A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Part
This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
| Condition(s) | B-cell Non-Hodgkin Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL). |
| Who can participate | Key Inclusion Criteria: * Eligible patients must be adults (≥18 years) * Documented diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per World Health Organization (WHO) 2021 classification. In the dose escalation phase, any B-NHL subtype is allowed (excluding some subtypes), while the backfill phase restricts inclusion to defined subtypes: large B-cell lymphomas (as defined as Diffuse large B-cell lymphoma (DLBCL), Grade 3b Follicular lymphoma (FL), double/triple hit lymphomas, high-grade (B-cell lymphoma) BCL, primary mediastinal Large B-cell lymphoma (LBCL), and transformed indolent lymphoma), mantle cell lymphoma, and follicular lymphoma grades 1-3a. * Patients must have relapsed or refractory disease after at least two prior lines of therapy and lack additional standard options with |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | AstraZeneca |
| Locations | Irvine, California, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; New York, New York, United States; New York, New York, United States; Cleveland, Ohio, United States (+16 more sites) |
| Start date | 2025-09-24 |
| NCT ID | NCT07123454 |
| Official listing | https://clinicaltrials.gov/study/NCT07123454 |