A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
NCT Number: NCT06564038
Acronym: Soundtrack-E
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Chronic Lymphocytic Leukaemia|Small Lymphocytic Leukaemia|Mantle-cell Lymphoma|Large B-cell Lymphoma|B-cell Non-Hodgkin Lymphoma
Interventions: DRUG: AZD0486|DRUG: Acalabrutinib|DRUG: Prednisone|DRUG: Rituximab|DRUG: Cyclophosphamide|DRUG: Vincristine|DRUG: Doxorubicin
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-13
Completion Date: 2031-01-31

Summary:
The purpose of this study is to assess the safety and efficacy of AZD0486 administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies.

Primary Outcome Measures: Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest, Safety and tolerability of AZD0486 as monotherapy and in combination with other anticancer agents across mature B-cell malignancies., Up to 6 years 4 months|Number of Participants with Dose Limiting Toxicity (DLTs), Safety and tolerability of AZD0486 as monotherapy and in combination with other anticancer agents across mature B-cell malignancies., Up to 2 months
Secondary Outcome Measures: Objective Response Rate (ORR), ORR is defined as percentage of participants achieving either a partial response (PR) or complete response (CR) based on response criteria for International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3)., Up to 6 years 4 months|Complete Response (CR) Rate, CR rate is defined as percentage of participants achieving CR as best response based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3)., Up to 6 years 4 months|Duration of Response (DoR), DoR is defined as time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator, relapse or death (substudy 1) and time from the date of first documented response until date of documented progression based on Lugano 2014 Response Criteria by investigator assessment, relapse or death (substudies 2 and 3)., Up to 6 years 4 months|Maximum Observed Concentration (Cmax), The PK (Cmax) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated., Up to 90 days after last dose|Area Under the Concentration-time Curve (AUC), The PK (AUC) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated., Up to 90 days after last dose|Minimum Observed Concentration (Cmin), The PK (Cmin) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated., Up to 90 days after last dose|Time to Reach Maximum Concentration (Tmax), The PK (Tmax) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated., Up to 90 days after last dose|Trough Plasma Concentration (Ctrough), The PK (Ctrough) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated., Up to 90 days after last dose|Half Life (t1/2) of AZD0486, The PK (t1/2) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated., Up to 90 days after last dose|Clearance (CL) of AZD0486, The PK (CL) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated., Up to 90 days after last dose|Number of Participants with Anti-drug Antibody (ADA) for AZD0486, The incidence of immunogenicity of SC AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated., Up to 90 days after last dose