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Epigenetic Modulator

AZD4573 + Acalabrutinib for Blood Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be ≥ 18 years of age at the time of signing the informed consent.
Diagnosis must be confirmed by biopsy and be immunohistologically characterised.
Must not have
History of or ongoing confirmed progressive multifocal leukoencephalopathy
Any of the following cardiac criteria: Resting QT interval corrected using Fridericia's formula (QTcF) ≥ 470 msec obtained from a single electrocardiogram (ECG); any clinically important abnormalities in rhythm (except for participants with a pacemaker in place), conduction or morphology of resting ECG); any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age. Concomitant medications known to prolong QTc should be used with caution and cannot be used starting with the first dose of study drug and through the DLT-assessment period (Part A) or during the scheduled ECG assessments.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 (5 weeks in total) on day 1 of week 1, 2 and 3, and cycle 2 (3 weeks in total) on day 1 of week 1
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, AZD4573, combined with another drug, acalabrutinib, for patients with certain blood cancers who haven't responded to other treatments. The drugs work together to kill cancer cells and block their growth. Acalabrutinib is more selective and has fewer side effects compared to an older drug.

Who is the study for?
This trial is for adults with advanced blood cancers who have tried at least two prior treatments without a cure in sight. They should not be eligible for curative therapies like CAR-T cell therapy and must have specific types of relapsed/refractory (r/r) blood cancers, such as DLBCL or MZL. Participants need to show active disease requiring treatment, adequate organ and bone marrow function, no recent transfusions or growth factor support, and an ECOG status ≤ 2.
What is being tested?
The study tests AZD4573 combined with other anti-cancer agents in patients with advanced blood cancer. It's an open-label Phase I/II trial where the drug is given intravenously. The goal is to find the right dose and see how well it works when paired with different cancer medications.
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to infusion of drugs, changes in blood counts leading to increased risk of infections or bleeding, fatigue from treatment-related anemia, digestive issues due to impact on gastrointestinal tract functions, and possible liver or kidney function alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My diagnosis was confirmed through a biopsy and detailed lab tests.
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I can take care of myself but might not be able to do heavy physical work.
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My tumor tissue can be sent to AstraZeneca for testing.
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My disease has come back or worsened after treatment.
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My cancer can be seen on scans and involves lymph nodes or tissues.
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I haven't had blood transfusions or growth factor support in the last 2 weeks.
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I have relapsed or refractory DLBCL or MZL and can provide a recent or archival tumor sample.
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I have tried at least two treatments for my current illness without success and cannot be cured with available treatments.
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My cancer can be seen on scans and involves lymph nodes or tissues.
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I have relapsed or refractory mantle cell lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.
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I have a heart condition or take medication that affects my heart's rhythm.
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I have been diagnosed with HIV.
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I need medication that strongly affects liver enzymes.
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I am on blood thinners like warfarin.
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I do not have any severe illnesses or infections that are not under control.
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I am currently being treated for adrenal gland insufficiency or pancreatitis.
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My myeloma does not produce detectable levels of M protein.
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I have or had brain lymphoma, leptomeningeal disease, or spinal cord compression.
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I have not had major heart or stroke issues in the last 6 months.
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I have severe stomach or bowel problems that affect how I digest food.
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I am currently taking both antiplatelet and anticoagulant medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 (5 weeks in total) on day 1 of week 1, 2 and 3, and cycle 2 (3 weeks in total) on day 1 of week 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 (5 weeks in total) on day 1 of week 1, 2 and 3, and cycle 2 (3 weeks in total) on day 1 of week 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Module 1 Part A : Number of participants with serious and non-serious adverse events
Module 1 Part B: Overall response rate (ORR) of AZD4573 in combination with acalabrutinib
Module 2 Part A : Number of participants with serious and non-serious adverse events
Secondary study objectives
Module 1 Part A and Part B; Module 2 Part A: Plasma PK (AUC0-t) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B; Module 2 Part A: Plasma PK (AUCinf) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B; Module 2 Part A: Plasma PK (AUClast) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
+9 more

Side effects data

From 2024 Phase 2 trial • 52 Patients • NCT05140382
100%
Blood bilirubin increased
100%
Aspartate aminotransferase increased
50%
Thrombocytopenia
50%
Haemorrhage intracranial
50%
Alanine aminotransferase increased
50%
Neutropenia
50%
Urinary tract infection
50%
Hypotension
50%
Cytokine release syndrome
50%
Sinus tachycardia
50%
Hypokalaemia
50%
Nausea
50%
Decreased appetite
50%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 NK PTCL
Cohort 3 cHL
Cohort 1 Non-NK PTCL

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Module 2: Part A and Part BExperimental Treatment2 Interventions
Participants will receive AZD4573 as monotherapy for Period 1 and AZD4573 + acalabrutinib as combination therapy for Period 2. Part B of Module 2 will be determined from the data emerging from Part A.
Group II: Module 1: Part A and Part BExperimental Treatment2 Interventions
Participants will receive intravenous ascending doses of AZD4573 once weekly with oral acalabrutinib twice daily continuously in Part A. For Part A, cohorts 1, 2, and 3 have different target dose levels respectively. In Part B, participants will receive the RP2D of AZD4573 from Part A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2080
AZD4573
2017
Completed Phase 2
~100

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for blood cancers include targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, such as CDK9 inhibitors like AZD4573, work by specifically inhibiting proteins essential for cancer cell survival and proliferation, thereby inducing cancer cell death. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells, but can also affect normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. These mechanisms are crucial for blood cancer patients as they offer more precise and potentially less toxic treatment options compared to traditional chemotherapy, improving outcomes and quality of life.
[The Onco-hematology clinical research unit at the Geneva University Hospital: example of a fruitful public-private partners].

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,375 Previous Clinical Trials
288,738,703 Total Patients Enrolled
1 Trials studying Blood Cancers
32 Patients Enrolled for Blood Cancers
ParexelIndustry Sponsor
308 Previous Clinical Trials
100,848 Total Patients Enrolled

Media Library

AZD4573 (Epigenetic Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04630756 — Phase 1 & 2
Blood Cancers Research Study Groups: Module 2: Part A and Part B, Module 1: Part A and Part B
Blood Cancers Clinical Trial 2023: AZD4573 Highlights & Side Effects. Trial Name: NCT04630756 — Phase 1 & 2
AZD4573 (Epigenetic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04630756 — Phase 1 & 2
~9 spots leftby Oct 2025