- A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies — Recruiting • Phase I • Oncology • NCT06564038.
- What is being tested: Safety and efficacy of surovatamig (AZD0486), a novel therapeutic agent, administered either alone or in combination with established anticancer drugs in patients with mature B-cell malignancies (hematological cancers).
- Patient eligibility overview: The trial recruits participants with diagnosed mature B-cell malignancies; specific eligibility criteria typically include disease stage, prior treatment history, organ function parameters, and performance status, though detailed inclusion/exclusion criteria would be defined in the full protocol.
- 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.
The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies
- : Master Inclusion Criteria applicable to all substudies: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Contraception use during treatment and at least 90 days after final dose. * Confirmed CD19 expression if prior anti-CD19 therapy. Substudy 1 Specific Inclusion Criteria: * Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. * SLL: at least 1 measurable site per Lugano. * Absolute lymphocyte count (ALC) 2 AEs from prior anticancer therapy (except alopecia or fatigue). * Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment. * Radiation therapy within 28 days. * Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks. * Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event. * Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1. * Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH). Substudy 1 Specific
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.