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A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants with Advanced Haematologic Malignancies with KMT2Ar, NPM1m, or Other Genotypes Associated with HOX Overexpression

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521299-76-00
Acronym
D8620C00001
Enrollment
17
Registered
2025-12-08
Start date
2025-12-18
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

Relapsed or refractory acute leukaemia or Myelodysplastic Syndromes with HOX overexpression genotypes

Brief summary

Module 1 - Incidence of DLT during the DLT evaluation period, Module 1 - Frequency of dose modifications, delays, and discontinuations due to AEs, Module 1 - Incidence TEAEs, TRAEs and SAEs, Module 1 - Changes from baseline in laboratory evaluations, 12-lead ECGs, performance status, physical examination, and vital signs, Module 2 - Frequency of dose modifications, delays, and discontinuations due to AEs, Module 2 - Incidence of TEAEs, TRAEs, and SAEs, Module 2 - Changes from baseline in laboratory evaluations, 12-lead ECGs, performance status, physical examination, and vital signs

Detailed description

Module 1 - Plasma concentrations and PK parameters, including but not limited to Cmax, Tmax, Ctrough, AUCinf, AUC0-t, AUCtau, CL/F, Vz/F, and t1/2 of AZD3632 as permitted by the data (additional PK parameters may be determined where appropriate), Module 1 - Plasma concentrations and PK parameters, including but not limited to Cmax, Cmin, Tmax, AUC0-t, AUCtau under fasted and fed state, Module 1 - Ratio of Cmax, AUC0-t and AUCtau between fed and fasted state, Module 1 - Acute leukaemia: Complete Response (CR) / Complete Response with partial Haematologic recovery (CRh) rate, Module 1 - Acute leukaemia: Time to response (TTR), Module 1 - Acute leukaemia: Duration of response (DoR), Module 1 - Acute leukaemia: Transfusion independence (TI), Module 1 - Acute leukaemia: Event-free survival (EFS), Module 1 - Acute leukaemia: Overall survival (OS), Module 1 - Acute leukaemia: Percentage of participants who receive subsequent allogeneic hematopoietic stem cell transplant (HSCT), Module 1 - Myelodysplastic Syndromes: Overall Response Rate (ORR): CR (or CR equivalent), Partial Response (PR), CRL, CRh, or haematologic improvement (HI), Module 1 - Myelodysplastic Syndromes: TTR, DoR, TI, Time to Progression to AML, EFS, OS, Percentage of participants who receive subsequent HSCT, Module 2 - Plasma PK parameters including but not limited to (AUC0-t, Cmax, and Tmax) of AZD3632 after administration of AZD3632 alone and in combination with posaconazole, Module 2 - Plasma GMR (Cmax and AUC) of AZD3632 evaluated with and without posaconazole, Module 2 - Plasma PK of posaconazole, Module 2 - Acute leukaemia: CR/CRh, TTR, DoR, TI, EFS, OS, percentage of participants who receive subsequent HSCT, Module 2 - Myelodysplastic Syndromes: ORR, TTR, DoR, TI, Time to progression to AML, EFS, OS, percentage of participants who receive subsequent HSCT

Interventions

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Module 1 - Incidence of DLT during the DLT evaluation period, Module 1 - Frequency of dose modifications, delays, and discontinuations due to AEs, Module 1 - Incidence TEAEs, TRAEs and SAEs, Module 1 - Changes from baseline in laboratory evaluations, 12-lead ECGs, performance status, physical examination, and vital signs, Module 2 - Frequency of dose modifications, delays, and discontinuations due to AEs, Module 2 - Incidence of TEAEs, TRAEs, and SAEs, Module 2 - Changes from baseline in laboratory evaluations, 12-lead ECGs, performance status, physical examination, and vital signs

Secondary

MeasureTime frame
Module 1 - Plasma concentrations and PK parameters, including but not limited to Cmax, Tmax, Ctrough, AUCinf, AUC0-t, AUCtau, CL/F, Vz/F, and t1/2 of AZD3632 as permitted by the data (additional PK parameters may be determined where appropriate), Module 1 - Plasma concentrations and PK parameters, including but not limited to Cmax, Cmin, Tmax, AUC0-t, AUCtau under fasted and fed state, Module 1 - Ratio of Cmax, AUC0-t and AUCtau between fed and fasted state, Module 1 - Acute leukaemia: Complete Response (CR) / Complete Response with partial Haematologic recovery (CRh) rate, Module 1 - Acute leukaemia: Time to response (TTR), Module 1 - Acute leukaemia: Duration of response (DoR), Module 1 - Acute leukaemia: Transfusion independence (TI), Module 1 - Acute leukaemia: Event-free survival (EFS), Module 1 - Acute leukaemia: Overall survival (OS), Module 1 - Acute leukaemia: Percentage of participants who receive subsequent allogeneic hematopoietic stem cell transplant (HSCT), Module 1 - My

Countries

Denmark, Germany, Italy

Outcome results

None listed

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