AZD3632
DrugAZD3632 will be administered orally.
NCT Number: NCT07155226
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.
Interested in participating?
Request Info16 year and older
All sexes
Interventional
Phase 1 / Phase 2
Research Site, Fitzroy, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Core criteria:
Module 1:
Module 2:
Key Exclusion Criteria:
Core criteria:
Module 1:
Module 2:
AZD3632 will be administered orally.
Posaconazole will be administered orally.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.
Time frame: Up to 3 years 1 month
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.
Time frame: Up to 30 days after last dose (approximately 3 years 1 month)
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: From Day 1 to 3 years 1 month
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
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
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
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
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
Time frame: From Day 1 to 3 years 1 month
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
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
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
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
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
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
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
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
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
Time frame: From Day 1 to 3 years 1 month
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
Time frame: From Day 1 to 3 years 1 month
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
Time frame: Up to 3 years 1 month
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
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
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
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: From Cycle 2 Day 1 (each cycle is 28 days) up to disease follow-up (approximately 3 years 1 month)
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)
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: Up to 3 years 1 month
Percentage of participants with acute leukaemia and MDS who receive subsequent allogeneic HSCT will be reported.
Time frame: Up to 3 years 1 month
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
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.
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
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
Acronym: MOMENTUM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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