Modular Study of AZD4573 in Advanced Haematological Malignancies
Research type
Research Study
Full title
A Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations with Anti-cancer Agents in Patients with Advanced Haematological Malignancies Module 1: AZD4573 plus Acalabrutinib in Participants with Relapsed or Refractory Diffuse Large B Cell Lymphoma (BLBCL)
IRAS ID
293543
Contact name
Charlotte Pai
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-001642-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 4 days
Research summary
The aim of the study is to assess AZD4573 in novel combinations with anti-cancer agents in patients with advanced haematological malignancies. Module 1 of the study assesses AZD4573 in combination with acalabrutinib in participants with relapsed or refractory diffuse large B cell lymphoma (DLBCL).
DLBCL is a cancer originating from B lymphocytes, which are white blood cells that are responsible for producing antibodies, as part of the body’s response against foreign substances and infections. “Relapsed or refractory” means the cancer has worsened during or after the last treatment(s). This is an experimental study where AZD4573 is administered along with acalabrutinib, which is another anti cancer drug.
AZD4573 is a new targeted treatment that may have the potential to provide clinical benefit (anti-tumour activity) in patients with relapsed or refractory DLBCL and for whom there is no other standard therapy available. The response to AZD4573 in combination with other anti-cancer agents like acalabrutinib, is anticipated to be better and the duration of response longer than AZD4573 as a single agent.
AZD4573 is given as a solution that is administered directly into the vein once a week. Acalabrutinib is taken orally, as a 100 mg capsule twice daily.
Participants receive the combination treatment as long as this is beneficial for the participant and no severe toxicities are experienced.
Module 1 consists of part A (dose setting) and part B (dose finding).
In Part A, up to 36 participants with r/r DLBCL, aged 18 years or above will take part at approximately 10 sites in about 5 countries.
In Part B, about 42 participants with r/r DLBCL will be enrolled into 2 groups (i.e., 21 participants in each group), depending on the DLBCL subtype, at approximately 30 sites in about 10 countries.
The study is being sponsored by AstraZeneca AB.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0043
Date of REC Opinion
26 Apr 2021
REC opinion
Further Information Favourable Opinion