- A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma — Recruiting • Phase I • Oncology • NCT07123454.
- Drug Being Tested: AZD4512, a novel investigational agent, is being evaluated as monotherapy or in combination with established anticancer agents in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
- Patient Eligibility Overview: The trial enrolls patients with B-NHL that has recurred after or become resistant to prior treatment, representing a population with limited therapeutic options and poor prognosis.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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).
- 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 survival benefit: A)LBCL patients must have progressed after both anti-CD20 and at least one systemic chemotherapy regimen, and have considered-or be ineligible for-CAR-T, T cell engager, and stem cell transplant modalities. B) Mantle cell lymphoma (MCL) patients must have had anti-CD20 and Bruton's Tyrosine Kinase (BTK) inhibitor. C)FL patients should have failed anti-CD20 with active disease requiring therapy. Additional criteria include measurable disease by Lugano 2014, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and adequate organ and bone marrow function (as specified by blood counts, cardiac ejection…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.