NCT06137118

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 163 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

Detailed description

This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.

Conditions

• B-cell Acute Lymphoblastic Leukemia (B-ALL)

Interventions

Type	Name	Description
DRUG	AZD0486	Investigational Product administered via intravenous infusion.

Timeline

• Start date: 2023-12-29
• Primary completion: 2026-11-13
• Completion: 2027-06-29
• First posted: 2023-11-18
• Last updated: 2026-01-16

Locations

79 sites across 13 countries: United States, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study