Tests surovatamig alone or with other drugs in B-cell blood cancers
Tests surovatamig, alone or combined, in adults with B-cell blood cancers.
Plain-language title generated from the registry record
Registry title: A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
Key facts
- Where
- Cologne, Homburg, Kiel, Mainz, Munich, and Wuerzburg, GermanySee the 6 sites
- Phase
- Phase 1/2
Where in Germany
- Universitaetsklinikum Koeln AöRCologne, GermanyTaking people
- Universitaet Des SaarlandesHomburg, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
- Klinikum der Universitaet Muenchen AöRMunich, GermanyTaking people
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06564038EU 2024-515034-33-00
- Record updated
- 28 October 2026
- Original description
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 malignanciesRead full original descriptionShow less
A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies
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
Inclusion: 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) <25000 cells/mcL; Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL; Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive; Substudy 2 Specific Inclusion Criteria:; MCL diagnosis per WHO; Clinical Stage II, III, or IV by Ann Arbor Classification; At least 1 measurable site per Lugano; ALC < 25000 cells/mcL; Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi; Substudy 3 Specific Inclusion Criteria:; At least 1 measurable site as per Lugano; Left ventricular ejection fraction (LVEF) ≥50%; Participant must be no older than 79 years of age at the time of signing ICF; Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin; Cohort 3A:; Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022; R/R B-NHL after at least 1 prior lines of systemic therapy; International Prognostic Index (IPI) 2-5; Cohort 3B:; Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022; IPI score of 2 to 5.
Exclusion: Surgery within 14 days of study drug; Unresolved Grade >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; Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist; Substudy 3 Specific Exclusion Criteria:; Clinically significant cardiovascular (CV) disease; Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH); Substudy 1 Specific Exclusion Criteria:; Master Exclusion Criteria applicable to all substudies:; Central nervous system (CNS) lymphoma; CLL/SLL transformation to more aggressive form of lymphoma; Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL); Cumulative dose of anthracycline >150 mg/m2.