NCT04865419

Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies

A Modular Phase I/II, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of AZD0466 as monotherapy in partciapants with advanced haematological malignancies and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.

Detailed description

The study consists of 2 individual modules as: Module 1 (AZD0466 monotherapy), and Module 2 (DDI study of AZD0466 with voriconazole). Eligible participants will be assigned to study treatments across Modules 1 and 2. 1. Module 1: AZD0466 monotherapy will include 2 parts- Part A dose escalation cohorts and Part B dose expansion cohorts. Initiation of Part B will depend on the evaluation of safety, tolerability, and PK in Part A. 2. Module 2: AZD0466 and voriconazole DDI study. All participants will receive AZD0466, and administration will continue until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment.

Conditions

• Haematological Malignancies

Interventions

Type	Name	Description
DRUG	AZD0466	AZD0466 powder for concentrate for solution for infusion will be administered by IV infusion.
DRUG	Voriconazole	Voriconazole film-coated tablet will be administered orally.

Timeline

• Start date: 2021-06-11
• Primary completion: 2023-08-08
• Completion: 2023-08-08
• First posted: 2021-04-29
• Last updated: 2025-06-15
• Results posted: 2025-06-15

Locations

15 sites across 6 countries: United States, Australia, France, Germany, Italy, South Korea

Regulatory

• FDA-regulated drug study