Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorAstraZeneca
About this trial
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
Eligibility criteria
Qualifiers
16 years old in Module 1 (US only: ≥18year)
12 years old in Module 2
Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts > 5% or reappearance of blasts in PB)
Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R
Disqualifiers
Burkitt lymphoma and leukemia
Isolated extramedullary disease; Active testicular or CNS (> CNS1) involvement
Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)
History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Trial design
Treatments tested in this trial
- AZD4512 monotherapy
Treatment groups
83 Participants
are divided into 2 treatment groupsLocations
26Australia
Research Site3000, Melbourne Australia
Canada
Research SiteV5Z 1M9, VancouverBritish Columbia, Canada
Research SiteM5G 1X6, TorontoOntario, Canada
China
Research Site510515, Guangzhou China
Sponsors and collaborators
AstraZeneca
Lead sponsor
Fortrea
Collaborator
Source ClinicalTrials.gov