NCT06564038

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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) The study will have the following sequential periods: 1. Screening period of 28 days 2. Treatment period 3. Follow-up period

Conditions

• Chronic Lymphocytic Leukaemia
• Small Lymphocytic Lymphoma
• Mantle-cell Lymphoma
• Large B-cell Lymphoma
• B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Surovatamig	Surovatamig will be administered as either SC injection or IV infusion.
DRUG	Prednisone (or equivalent)	Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
DRUG	Rituximab	Rituximab will be administered as IV infusion as per standard of care.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered as IV infusion as per standard of care.
DRUG	Vincristine	Vincristine will be administered as IV infusion as per standard of care.
DRUG	Doxorubicin	Doxorubicin will be administered as IV infusion as per standard of care.
DRUG	Acalabrutinib	Acalabrutinib will be administered orally

Timeline

• Start date: 2025-01-30
• Primary completion: 2028-02-28
• Completion: 2029-06-11
• First posted: 2024-08-21
• Last updated: 2026-04-13

Locations

64 sites across 13 countries: United States, Australia, China, Czechia, Denmark, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study