AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Blood Cancer.

  • STATUS
    Recruiting
  • End date
    Jul 24, 2023
  • participants needed
    78
  • sponsor
    AstraZeneca
Updated on 20 July 2021

Summary

This is a modular, multicentre, open-label, non-randomised, Phase I/II, dose-setting and expansion study including an intra-participant ramp-up.

AZD4573 will be administered intravenously, in novel combinations with anti-cancer agents, to participants with relapsed/refractory haematological malignancies.

Description

In Module 1 Part A (dose-setting), this study module will initially explore once weekly administration of AZD4573 at up to three target dose levels in combination with oral acalabrutinib 100 mg twice daily and will enroll participants with Diffuse large B-cell lymphoma (DLBCL), based on the observation of complete and partial responses amongst DLBCL patients treated with monotherapy. The primary objective of Part A will be to identify the maximum tolerated dose and/or Recommended Phase II dose (RP2D) for further evaluation in Part B.

In Module 1 Part B (expansion), separate expansion cohorts for participants with Germinal Centre B-cell (GCB) and non-GCB DLBCL subtypes will be opened at the RP2D.

Details
Condition Advanced Haematological Malignancies
Treatment acalabrutinib, AZD4573
Clinical Study IdentifierNCT04630756
SponsorAstraZeneca
Last Modified on20 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be 18 years of age at the time of signing the informed consent
Participants with histologically confirmed, relapsed or refractory DLBCL, and where in the opinion of the investigator, a clinical trial is the best option for next treatment based on response and/or tolerability to prior lines of therapy. PART A
Diagnosis must be confirmed by biopsy and be immunohistologically characterized
Tumour tissue must also be available for sending to AstraZeneca for central cell of origin/pathology testing. PART B
Must have received standard of care first line therapy
Diagnosis must be confirmed by biopsy and be immunohistologically characterised
A newly obtained tumour biopsy is mandatory at screening to confirm cell of origin status and determine DLBCL subtype
Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
Participants must have failed at least 2 prior therapies for the treatment of current disease, are not eligible for curative treatment options, and have no standard therapy available
Adequate haematologic function, without transfusion and growth factor support for
days before screening
Optional tumour biopsy on study: Participants are also encouraged to consent to and undergo an optional tumour biopsy at disease progression to support correlative biomarker studies
All participants must be willing and able to provide mandatory baseline bone marrow biopsy/aspirate

Exclusion Criteria

Treatment with prior Bruton's tyrosine kinase inhibitor
Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
Prior use of standard anti-lymphoma therapy or radiation therapy within 14 days of receiving the first dose of study treatment
Requires treatment with strong CYP3A inhibitors or inducers
Requires treatment with proton-pump inhibitors. Participants receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrolment to this study
Serologic status reflecting active hepatitis B or C infection
Active Cytomegalovirus (CMV) infection
Receipt of live, attenuated vaccine within 28 days before the first dose of study treatment (s)
Requires or receiving therapeutic anticoagulants, with the exception of short-acting heparins, within 7 days of first dose of study treatment
Participants on dual antiplatelet and therapeutic anticoagulant therapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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