AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorAstraZeneca
About this trial
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)
Eligibility criteria
Qualifiers
Age: 12 years and above (Parts A, B and C).
Bone marrow infiltration with >/= 5% blasts
Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.
Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs.
Disqualifiers
Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria).
Isolated extramedullary disease relapse.
Testicular leukemia
History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.
Trial design
Treatments tested in this trial
- AZD0486
Treatment groups
236 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov