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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-03

Study Completion Date

2028-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

NCT06137118

B-cell Acute Lymphoblastic Leukemia (B-ALL)

RECRUITING PHASE1/PHASE2

Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies

NCT03263637

Relapsed or Refractory Haematological Malignancies Including Acute Myeloid Leukemia Acute Lymphocytic Leukemia +8 more

COMPLETED PHASE1

Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia

NCT00497991

Myeloid Leukemia

COMPLETED PHASE1

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

NCT07008118

Myeloproliferative Neoplasms

RECRUITING PHASE1

Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

NCT04501120

Relapsed/Refractory Acute Myeloid Leukaemia Myeloid Malignancy

RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a modular study. In Module 1, the study will begin with a dose escalation of AZD2962 monotherapy in participants with myelodysplastic syndromes (MDS) and dysplastic chronic myelomonocytic leukemia (CMML).

Module 1 of the study will comprise of:

1. A Screening Period of maximum 21 days.
2. Treatment period with 28-day cycles where each patient will receive an oral dose of AZD2962 once daily, starting on Day 1, and will continue treatment until disease progression, unacceptable toxicity, or withdrawal.
3. Safety Follow-up period after 30 days after last dose.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Haematologic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Module 1- AZD2962 (Monotherapy)

Participants with MDS and dysplastic CMML will receive AZD2962 as monotherapy in a dose escalation pattern.

Group Type EXPERIMENTAL

AZD2962

Intervention Type DRUG

AZD2962 will be administered orally once daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD2962

AZD2962 will be administered orally once daily.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts \< 20%, and who received one or more prior lines of therapy as per standard of care (or who exhausted locally available treatments including treatments for actionable mutations). Diagnosis must be histologically confirmed as per the WHO 2016 classification of myeloid neoplasms.
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
3. Participants must have symptomatic disease that requires therapy and allows for objective efficacy assessments.
4. Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
5. Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol requirements.
6. All women of childbearing potential must have a negative serum pregnancy test result at Screening.

Exclusion Criteria

1. Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
2. Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
3. Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
4. Received major surgery within 28 days prior to first dose, or still recovering from surgery.
5. Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes, within 15 days prior to first dose.
6. Received immunosuppressive medications (including Graft-Versus-Host Disease prophylaxis) within 28 days prior to first dose, or within 15 days in the case of systemic steroids (doses exceeding 10 mg/day of prednisone or equivalent).
7. Received live attenuated vaccines within 28 days prior to first dose.
8. Active major bleeding event.
9. Any evidence of systemic disease, significant clinical disorder, or laboratory finding that make undesirable the participation in the study.

15\. Mean resting corrected QT interval using Fridericia's formula (QTcF) \> 450 ms obtained from triplicate Electrocardiograms (ECGs) and averaged, recorded within 5 minutes. In the presence of bundle branch block, QTcF \> 470 ms is applicable.

16\. History of intracranial bleeding within 6 months prior to first dose. 17. Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism or excretion of oral therapy.

18\. History of a prior non-haematologic neoplasm (with some exceptions). 19. Unresolved Grade \> 2 toxicities from prior anticancer therapies (with some exceptions).

20\. Concurrent enrolment in another clinical study (with some exceptions). 21. Known hypersensitivity to study intervention or its excipients.

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No