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

NCT 06564038

Brief 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.

Intervention / Treatment 

  • Drug: AZD0486
  • Drug: Acalabrutinib
  • Drug: Prednisone
  • Drug: Rituximab
  • Drug: Cyclophosphamide
  • Drug: Vincristine
  • Drug: Doxorubicin

Inclusion Criteria:

Master Inclusion Criteria applicable to all substudies:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Contraception during treatment and at least 6 months 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 lymphocytes <10,000.
  • Cohort 1A: at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i).
  • Cohort 1B: at least 1 prior line of therapy and is 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 < 10,000.
  • Cohort 2A: Relapse or progressed after 2 or more lines of therapy including BTKi.
  • Cohort 2B: Relapse or progressed after 1 or more line of therapy, not including a BTKi.

Substudy 3 Specific Inclusion Criteria:

  • Large B-cell lymphoma per WHO 2022.
  • R/R B-NHL after at least 1 prior line of therapy.
  • International Prognostic Index (IPI) 2-5.
  • At least 1 measurable site as per Lugano.
  • Left ventricular ejection fraction (LVEF) >50%.
  • Contraception at least 12 months after last dose of R-CHOP or 6 months after last dose of AZD0486.

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