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 groupsSponsors and collaborators
AstraZeneca
Lead sponsor
Fortrea
Collaborator
Source ClinicalTrials.gov