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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 Hematologic Neoplasms

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520786-44-00
Acronym
D7770C00001
Enrollment
7
Registered
2025-08-11
Start date
2025-10-21
Completion date
Unknown
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplastic chronic myelomonocytic leukaemia, Myelodysplastic syndromes

Brief summary

Incidence of DLTs during the DLT observation period., Incidence, severity, and relationship to IMP, of AEs and SAEs., Changes from baseline in laboratory evaluations, vital signs, physical examinations, and ECG results., Duration of exposure and relative dose intensity.

Detailed description

Objective Response, as assessed by the response criteria corresponding to the different haematologic neoplasms., Duration of Response, Time to Response, Overall Survival, and Time to progression to AML., Plasma concentrations of AZD2962., Plasma PK parameters of AZD2962 (including but not limited to AUC, Cmax, and tmax, as data allow).

Interventions

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of DLTs during the DLT observation period., Incidence, severity, and relationship to IMP, of AEs and SAEs., Changes from baseline in laboratory evaluations, vital signs, physical examinations, and ECG results., Duration of exposure and relative dose intensity.

Secondary

MeasureTime frame
Objective Response, as assessed by the response criteria corresponding to the different haematologic neoplasms., Duration of Response, Time to Response, Overall Survival, and Time to progression to AML., Plasma concentrations of AZD2962., Plasma PK parameters of AZD2962 (including but not limited to AUC, Cmax, and tmax, as data allow).

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026