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
AstraZeneca
Summary
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.
Description
This is open-label, multi-center study to evaluate the safety and preliminary efficacy of surovatamig administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies. This master study currently includes 3 substudies and each substudy focusing on a defined population: Substudy 1: Relapsed/refractory (R/R) Chronic lymphocytic leukaemia (CLL)/ Small lymphocytic lymphoma (SLL) Substudy 2: R/R Mantle-cell lymphoma (MCL) Substudy 3: Large B-cell lymphoma (LBCL) or R/R B-cell non-Hodgkin lymphoma (B-NHL) (not applicable to US)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 l…
Interventions
- DrugSurovatamig
Surovatamig will be administered as either SC injection or IV infusion.
- DrugPrednisone (or equivalent)
Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
- DrugRituximab
Rituximab will be administered as IV infusion as per standard of care.
- DrugCyclophosphamide
Cyclophosphamide will be administered as IV infusion as per standard of care.
- DrugVincristine
Vincristine will be administered as IV infusion as per standard of care.
- DrugDoxorubicin
Doxorubicin will be administered as IV infusion as per standard of care.
- Drug
Locations (64)
- Research SiteBoston, Massachusetts
- Research SiteHackensack, New Jersey
- Research SiteNew Brunswick, New Jersey
- Research SiteNew York, New York
- Research SiteNew York, New York
- Research SiteCharlotte, North Carolina