Haematologic NeoplasmsPhase 1NCT07064122
A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)
A Phase 1 study testing AZD2962 in people with Haematologic Neoplasms, run by AstraZeneca at 21 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Haematologic Neoplasms
- What is being tested?
- AZD2962
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 3 Nov 2025to 20 Oct 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Participants must have symptomatic disease that requires therapy and allows for objective efficacy assessments.
- Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
- Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol requirements.
- All women of childbearing potential must have a negative serum pregnancy test result at Screening.
Who cannot join
- Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
- Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
- Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
- Received major surgery within 28 days prior to first dose, or still recovering from surgery.
- 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.
- 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).
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- Received live attenuated vaccines within 28 days prior to first dose.
- Active major bleeding event.
- 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.
Trial locations and contacts
21 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
21 sites in 7 countries
Spain6 sites, 5 recruiting
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Madrid, 28027
- Recruiting
Research Site
Madrid, 28033
- Recruiting
Research Site
Pamplona, 31008
- Recruiting
Research Site
Salamanca, 37007
- Withdrawn
Research Site
Valencia, 46026
United States3 sites, 3 recruiting
- Recruiting
Research Site
Houston, Texas, 77030
- Not yet recruiting
Research Site
Miami, Florida, 33136
- Recruiting
Research Site
Tampa, Florida, 33612
Taiwan3 sites, 3 recruiting
- Not yet recruiting
Research Site
Kaohsiung City, 83301
- Not yet recruiting
Research Site
Tainan, 70403
- Recruiting
Research Site
Taipei, 100
United Kingdom3 sites, 3 recruiting
- Recruiting
Research Site
London, SE5 9RS
- Recruiting
Research Site
London, W1T 7HA
- Recruiting
Research Site
Manchester, M20 4BX
Australia2 sites, 2 recruiting
- Recruiting
Research Site
Heidelberg, 3084
- Recruiting
Research Site
Melbourne, 3000
Japan2 sites, 2 recruiting
- Recruiting
Research Site
Shinagawa-ku, 141-0022
- Recruiting
Research Site
Yoshida-gun, 910-1193
South Korea2 sites
- Withdrawn
Research Site
Seoul, 05505
- Withdrawn
Research Site
Seoul, 3722
About this study
Official title: A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AZD2962, an IRAK4 Inhibitor, as Monotherapy and in Combination With Other Agents, in Participants With Haematologic Neoplasms
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.
Read the detailed description
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:
- A Screening Period of maximum 21 days.
- 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.
- Safety Follow-up period after 30 days after last dose.
- Conditions
- Haematologic Neoplasms
- Being tested
- AZD2962
- Keywords
- Interleukin-1 receptor associated kinase 4 (IRAK4) inhibitor, Modular study, Pharmacokinetics, Dose escalation
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2962Drug
AZD2962 will be administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Module 1- AZD2962 (Monotherapy) | Experimental | Participants with MDS and dysplastic CMML will receive AZD2962 as monotherapy in a dose escalation pattern. Receives: Drug: AZD2962 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicity (DLT)
A DLT is defined as an adverse event or abnormal laboratory value occurring during the DLT-evaluation period (first 28 days of treatment). This will be evaluated to assess the safety and tolerability and also to identify optimal biological dose (OBD) of AZD2962.
Measured: From Cycle 1 Day 1 up to end of Cycle 1 (28 Days)
Number of participants with Adverse events (AEs) and serious AEs
To assess the safety and tolerability of AZD2962 and also to identify OBD of AZD2962.
Measured: Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)
Duration of exposure
To assess the safety and tolerability of AZD2962, and also to identify OBD of AZD2962.
Measured: Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)
Relative dose intensity
To assess the safety and tolerability of AZD2962, and also to identify OBD of AZD2962.
Measured: Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)
Secondary outcomes (9)
Percentage of participants with Objective response (OR)
For participants with MDS or CMML, OR is defined as the achievement of Best Overall Response (BOR) assessed by relevant criteria for the selected haematologic neoplasm. The OR will be assessed to estimate the efficacy of AZD2962.
Measured: First dose up to progression of disease (PD) or last evaluable assessment in the absence of progression, whichever comes first (Approximately 3 Years)
Duration of response (DoR)
The DoR is defined as the time from the date of first documented OR until date of first documented PD or death (by any cause in the absence of PD), regardless of discontinuation of study interventions or receiving another anticancer therapy. The DoR will be assessed to estimate the efficacy of AZD2962.
Measured: First documented response, up to the date of the first documented PD or study end, which ever comes first (Approximately 3 Years)
Time to Response (TTR)
The TTR is defined as the time between start of treatment and the date of documented confirmed objective response for the selected haematologic neoplasm. The TTR will be assessed to estimate the efficacy of AZD2962.
Measured: First dose up to PD or last evaluable assessment, whichever comes first (Approximately 3 Years)
Overall Survival (OS)
The OS is defined as the time from the date of first dose until death due to any cause regardless of whether the participant withdraws from study therapy or receives another anti-cancer therapy. The OS will be assessed to estimate the efficacy of AZD2962.
Measured: First dose up to death due to any cause (Approximately 3 Years)
Time to Progression to Acute myeloid leukaemia (AML)
Time to progression to AML as per World Health Organization (WHO) 2016 is defined from the time of first dose until first diagnosis of AML, regardless of discontinuation of treatment or receiving another anti-cancer therapy. This will be assessed to estimate the efficacy of AZD2962.
Measured: First dose up to first diagnosis of AML (Approximately 3 Years)
Plasma concentration of AZD2962
To characterise the plasma concentration of AZD2962 as monotherapy.
Measured: Cycle 1 Day 1 (each cycle is 28 days) up to end of the treatment (EoT) (Approximately 3 Years)
Area under the concentration time curve (AUC).
To characterise the pharmacokinetics (PK) AUC of AZD2962 as monotherapy.
Measured: Cycle 1 Day 1 (each cycle is 28 days) up to EoT (Approximately 3 Years)
Maximum plasma drug concentration (Cmax)
To characterise the PK (Cmax) of AZD2962 as monotherapy.
Measured: Cycle 1 Day 1 (each cycle is 28 days) up to EoT (Approximately 3 Years)
Time to reach maximum concentration (tmax)
To characterise the PK (tmax) of AZD2962 as monotherapy.
Measured: Cycle 1 Day 1 (each cycle is 28 days) up to EoT (Approximately 3 Years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start3 Nov 2025
- Primary completion20 Oct 2028 (estimated)
- Study completion20 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064122
- Sponsor's protocol ID
- D7770C00001
- Other IDs
- 2025-520786-44, 172349, 2025
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.