A Phase 1/2 interventional study of AZD3632 and Posaconazole in Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia and Higher-risk Myelodysplastic Syndromes, sponsored by AstraZeneca. Recruiting at 30 sites in 9 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.
This is a first in human (FTiH), open-label, multi-centre study of AZD3632 in participants with relapsed or refractory acute leukaemia or myelodysplastic Syndromes (MDS) with HOX overexpression genotypes.
This study includes multiple modules (module 1 and module 2) each investigating AZD3632 in a specific population and/or in combination with other anticancer agents.
Module 1 is a dose escalation of AZD3632 monotherapy. Module 2 will investigate the safety, PK, and tolerability when co-administered with posaconazole.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 491 are open to participants now.
This study's planned enrollment of 84 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Core criteria:
Module 1:
Module 2:
Key Exclusion Criteria:
Core criteria:
Module 1:
Module 2:
Participants will receive AZD3632 (dose 1) through the treatment period.
Drug: AZD3632
Participants will receive AZD3632 (dose 2) through the treatment period.
Drug: AZD3632
Participants will receive AZD3632 (dose 3) through the treatment period.
Drug: AZD3632
Participants will receive AZD3632 (dose 4) through the treatment period.
Drug: AZD3632
Participants will receive AZD3632 (dose 5) through the treatment period.
Drug: AZD3632
Participants will receive AZD3632 (dose 6) through the treatment period.
Drug: AZD3632
Participants will receive AZD3632 alone, then will receive AZD3632 in combination with posaconazole through treatment period.
Drug: AZD3632 · Drug: Posaconazole
AZD3632 will be administered orally.
Posaconazole will be administered orally.
Module 1: Number of participants with dose-limiting toxicity (DLT)
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Module 1 and Module 2: Number of participants with dose modification, delay and discontinuations due to adverse events (AEs)
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.
Time frame: Up to 3 years 1 month
Module 1 and Module 2: Number of participants with treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs) and serious adverse vents (SAEs)
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed. Adverse events will be defined as treatment-emergent if they have an onset or worsen (by investigator report of a change in intensity) during the study treatment or the safety follow-up period but prior to any subsequent cancer therapy.
Time frame: Up to 30 days after last dose (approximately 3 years 1 month)
Module 1 and Module 2: Maximum concentration (Cmax) of AZD3632
The PK of AZD3632 as monotherapy (module 1) and in combination with posaconazole (module 2) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1 and Module 2: Time of maximum concentration (Tmax) of AZD3632
The PK of AZD3632 as monotherapy (module 1) and in combination with posaconazole (module 2) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Trough concentration (Ctrough) of AZD3632
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Area under the plasma concentration-time Curve from Time Zero to Infinity (AUC[inf]) of AZD3632
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1 and Module 2: Area under the curve from time 0 to the time of last measurable concentration (AUC[0-t]) of AZD3632
The PK of AZD3632 as monotherapy (module 1) and in combination with posaconazole (module 2) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Area under concentration-time curve in the dosing interval (AUCtau) of AZD3632
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Apparent total body clearance (CL/F) of AZD3632
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Apparent volume of distribution based on the terminal phase (VZ/F) of AZD3632
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Half-life (t1/2) of AZD3632
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Maximum concentration (Cmax) of AZD3632 (food effect)
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Time of maximum concentration (Tmax) of AZD3632 (food effect)
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1 and Module 2: Area under the curve from time 0 to the time of last measurable concentration (AUC[0-t]) of AZD3632 (food effect)
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Area under concentration-time curve in the dosing interval (AUCtau) of AZD3632 (food effect)
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Minimum concentration (Cmin) of AZD3632 (food effect)
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Ratio of Cmax between fed and fasted state
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Ratio of AUC(0-t) between fed and fasted state
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1: Ratio of AUCtau between fed and fasted state
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 2: Plasma geometric mean ratio of Cmax
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 2: Plasma geometric mean ratio of AUC
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 2: Plasma concentration of posaconazole
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
Time frame: From Day 1 to 3 years 1 month
Module 1 and Module 2: Complete response rate (CR + CRh)
Complete response rate is defined as the percentage of participants who have a complete remission (CR) or complete remission with partial haematological recovery (CRh) as assessed by the investigator at local site.
Time frame: Up to 3 years 1 month
Module 1 and Module 2: Time to response (TTR)
TTR in participants with acute leukaemia is defined as the time from date of first dose until date of first documented complete response (CR/CRh) among participants with acute leukaemia in the Response Evaluable Set who achieved complete response as assessed by investigator at local site. TTR in participants with MDS is defined as the time from date of first dose until date of first documented objective response a CR (or CR equivalent), complete response with limited count recovery \[CRL\], CRh, partial response \[PR\], or haematologic improvement \[HI\]) among participants with MDS in the Response Evaluable Set who achieved objective response as assessed by investigator at local site.
Time frame: Up to 3 years 1 month
Module 1 and Module 2: Duration of response (DoR)
DoR in participants with acute leukaemia is defined as the time from date of first documented complete response (CR/CRh) until date of first documented relapse or death (by any cause in the absence of relapse) as assessed by investigator at local site. DoR in participants with MDS is defined as the time from date of first documented objective response CR (or CR equivalent), CRL, CRh, PR, or HI until date of first documented relapse or death (by any cause in the absence of relapse) as assessed by investigator at local site.
Time frame: Up to 3 years 1 month
Module 1 and Module 2: Transfusion Independence (TI)
TI is defined as no RBC and no platelet transfusion during any consecutive period of at least 56 days post-baseline after starting treatment with AZD3632 or cessation of treatment with AZD3632 but prior to start of subsequent new therapy.
Time frame: Up to 3 years 1 month
Module 1 and Module 2: Event-free Survival (EFS)
EFS for participants with acute leukaemia is defined as the time from date of first dose until date of relapse, progressive disease, failure to achieve at least Morphologic leukaemia-free state (MLFS) by end of Cycle 6, or death due to any cause as assessed by investigator at a local site. EFS for participants with MDS is defined as the time from date of first dose until date of relapse, progressive disease, failure to achieve at least HI by end of Cycle 6, or death due to any cause.
Time frame: From Cycle 2 Day 1 (each cycle is 28 days) up to disease follow-up (approximately 3 years 1 month)
Module 1 and Module 2: Overall Survival (OS)
OS is defined as the time from date of first dose until date of death due to any cause regardless of whether the participant withdraws from study therapy or receives another anticancer therapy.
Time frame: From Cycle 2 Day 1 (each cycle is 28 days) up to disease follow-up (approximately 3 years 1 month)
Module 1 and Module 2: Percentage of participants who receive subsequent allogeneic hematopoietic stem cell transplant (HSCT)
Percentage of participants with acute leukaemia and MDS who receive subsequent allogeneic HSCT will be reported.
Time frame: Up to 3 years 1 month
Module 1 and Module 2: Overall Response Rate (ORR)
ORR in participants with myelodysplastic syndromes (MDS) is defined as the percentage of participants who have a CR (or CR equivalent), CRL, CRh, PR, or HI as determined by investigator at a local site.
Time frame: Up to 3 years 1 month
Module 1 and Module 2: Time to Progression to acute myeloid leukaemia (AML)
Time to progression to AML is defined from the time of first dose of AZD3632 until first diagnosis of AML, regardless of discontinuation of treatment or receiving of subsequent therapy.
Time frame: Up to 3 years 1 month
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portalVivli.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.
Supporting information: Study protocol, Sap
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