Study 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
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD3632: AZD3632 will be administered orally.
Posaconazole: Posaconazole will be administered orally.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Module 1: Number of participants with dose-limiting toxicity (DLT) — 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. - Module 1 and Module 2: Number of participants with dose modification, delay and discontinuations due to adverse events (AEs) — Up to 3 years 1 month
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed. - Module 1 and Module 2: Number of participants with treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs) and serious adverse vents (SAEs) — 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.
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Decatur | Illinois | Recruiting |
| Research Site | New York | New York | Not Yet Recruiting |
| Research Site | Chapel Hill | North Carolina | Not Yet Recruiting |
| Research Site | Durham | North Carolina | Recruiting |
| Research Site | Portland | Oregon | Suspended |
| Research Site | Houston | Texas | Recruiting |
| Research Site | Fitzroy | Australia | Suspended |
| Research Site | Perth | Australia | Suspended |
| Research Site | Toronto | Ontario | Suspended |
| Research Site | Montreal | Quebec | Suspended |
| Research Site | Copenhagen | Denmark | Recruiting |
| Research Site | Dresden | Germany | Recruiting |
| Research Site | Frankfurt A. Main | Germany | Recruiting |
| Research Site | Halle | Germany | Recruiting |
| Research Site | Heidelberg | Germany | Recruiting |
| Research Site | München | Germany | Recruiting |
| Research Site | Ulm | Germany | Recruiting |
| Research Site | Bologna | Italy | Recruiting |
| Research Site | Ravenna | Italy | Recruiting |
| Research Site | Bunkyō City | Japan | Recruiting |
| Research Site | Kashiwa | Japan | Not Yet Recruiting |
| Research Site | Okayama | Japan | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Edinburgh | United Kingdom | Recruiting |
| Research Site | London | United Kingdom | Recruiting |
| Research Site | London | United Kingdom | Recruiting |
| Research Site | Manchester | United Kingdom | Recruiting |
| Research Site | Newcastle | United Kingdom | Suspended |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07155226 on ClinicalTrials.gov ↗ ← All trials in Italy