Actively Recruiting

Phase 1
Age: 18Years - 110Years
All Genders
NCT07064122

A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)

Led by AstraZeneca · Updated on 2026-03-02

72

Participants Needed

21

Research Sites

154 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

P

Parexel

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of the study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD2962, an Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor, as monotherapy and in combination with other agents in participants with haematologic neoplasms.

CONDITIONS

Official Title

A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with relapsed or refractory MDS or dysplastic CMML with peripheral or bone marrow blasts less than 20%, having received one or more prior lines of therapy.
  • Histologically confirmed diagnosis based on WHO 2016 classification of myeloid neoplasms.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
  • Symptomatic disease requiring therapy and allowing objective efficacy assessments.
  • Willingness to provide baseline bone marrow aspirate or biopsy if needed.
  • Use of contraception consistent with local regulations and study protocol.
  • Women of childbearing potential must have a negative serum pregnancy test at screening.
Not Eligible

You will not qualify if you...

  • Prior treatment with IRAK inhibitors or inflammasome pathway inhibitors.
  • Antineoplastic therapy (except hydroxyurea) within 15 days before first dose.
  • Use of strong or moderate CYP3A inhibitors within 15 days before first dose.
  • Major surgery within 28 days before first dose or not fully recovered from surgery.
  • Use of drugs that prolong QT interval or risk Torsades de Pointes within 15 days before first dose.
  • Immunosuppressive medications within 28 days before first dose, or systemic steroids over 10 mg/day prednisone equivalent within 15 days.
  • Live attenuated vaccines within 28 days before first dose.
  • Active major bleeding event.
  • Any systemic disease, significant clinical disorder, or lab abnormality making study participation undesirable.
  • Mean resting corrected QT interval (QTcF) over 450 ms (470 ms if bundle branch block) on ECG.
  • History of intracranial bleeding within 6 months before first dose.
  • Active gastrointestinal disease or condition interfering with oral therapy absorption.
  • History of prior non-haematologic cancer (with some exceptions).
  • Unresolved Grade over 2 toxicities from prior anticancer therapies (with some exceptions).
  • Concurrent enrollment in another clinical study (with some exceptions).
  • Known hypersensitivity to study drug or its components.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 21 locations

1

Research Site

Miami, Florida, United States, 33136

Not Yet Recruiting

2

Research Site

Tampa, Florida, United States, 33612

Actively Recruiting

3

Research Site

Houston, Texas, United States, 77030

Actively Recruiting

4

Research Site

Heidelberg, Australia, 3084

Actively Recruiting

5

Research Site

Melbourne, Australia, 3000

Actively Recruiting

6

Research Site

Shinagawa-ku, Japan, 141-0022

Actively Recruiting

7

Research Site

Yoshida-gun, Japan, 910-1193

Actively Recruiting

8

Research Site

Seoul, South Korea, 05505

Withdrawn

9

Research Site

Seoul, South Korea, 3722

Withdrawn

10

Research Site

Barcelona, Spain, 08035

Actively Recruiting

11

Research Site

Madrid, Spain, 28027

Actively Recruiting

12

Research Site

Madrid, Spain, 28033

Actively Recruiting

13

Research Site

Pamplona, Spain, 31008

Actively Recruiting

14

Research Site

Salamanca, Spain, 37007

Actively Recruiting

15

Research Site

Valencia, Spain, 46026

Withdrawn

16

Research Site

Kaohsiung City, Taiwan, 83301

Not Yet Recruiting

17

Research Site

Tainan, Taiwan, 70403

Not Yet Recruiting

18

Research Site

Taipei, Taiwan, 100

Actively Recruiting

19

Research Site

London, United Kingdom, SE5 9RS

Actively Recruiting

20

Research Site

London, United Kingdom, W1T 7HA

Actively Recruiting

21

Research Site

Manchester, United Kingdom, M20 4BX

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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