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AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
PHASE1PHASE2RECRUITING
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).
Study details:
This dose escalation and optimization study is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy in r/r B-ALL.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-29
Primary completion: 2026-01-29
Study completion finish: 2027-02-04
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06137118
Intervention or treatment
DRUG: AZD0486
Conditions
- • B-cell Acute Lymphoblastic Leukemia (B-ALL)
Find a site
Closest Location:
Research Site
Research sites nearby
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Research Site
Melbourne, Not Specified, Australia
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Part A: AZD0486 Dose Escalation
| DRUG: AZD0486
|
EXPERIMENTAL: Part B: Dose Optimization
| DRUG: AZD0486
|
EXPERIMENTAL: Part C: Dose Expansion
| DRUG: AZD0486
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Part A: Frequency of DLTs | DLTs are dose-limiting toxicities as defined in the study protocol | 28 days |
| Parts A & B: Safety Evaluation of AZD0486 | Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in laboratory evaluations; QTc, and vital signs changes. | From signing of informed consent through completion of study treatment, an average of 8 months |
| Parts B & C: Overall Response Rate (ORR) | The Primary analysis for ORR be conducted in RP2D-treated participants (in Part B and C). | From First dose to end of treatment or data cutoff, whichever comes first, assessed up to 24 months |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Part A: Objective Response Rate (ORR) | Overall response rate (ORR) is defined as proportion of participants who achieve overall response (CR/CRi). | From First dose to end of treatment or data cutoff, whichever comes first, assessed up to 12 months |
| Parts A, B, C: Duration of response (DoR) | Date of first documented CR/CRi until the date of relapse or death | Up to 36 months |
| Parts A, B, C: CR rate at any time during the study | CR rate as defined as the percentage of participants achieving CR at any time by NCCN criteria | From first dose until end of study, up to 36 months |
| Parts A, B, C: Event-free survival (EFS) | Event-free survival is defined as the time from the date of the first dose until the date of a relapse after achieving a CR/ CRi, or death due to any cause. | From first dose until end of study, up to 36 months |
| Parts A, B, C: Overall survival (OS) | OS measured from first dose of study drug until death | From first dose until end of study, up to 36 months |
| Parts B & C: Subsequent alloSCT | Number of patients who after achieve CR/CR underwent an alloSCT | From first dose until end of study, up to 24 months |
| Parts B &C: CR MRD-negative rate | Number of patients who achieve CR MRD-negative by NGS at any time on study | First dose until end of study, up to 24 months |
| Parts A, B, & C: PK characterization of AZD0486 | Derived PK parameter: AUC | From first dose until end of study, up to 36 months |
| Parts A, B & C: PK Characterization of AZD0486 | Derived PK parameter: Cmax | From first dose until end of study, up to 36 months |
| Parts A, B, C: PK Characterization of AZD0486 | Derived PK Parameter: tmax | From first dose until end of study, up to 36 months |
| Parts A, B, C: PK Characterization of AZD0486 | Derived PK parameter: Ctrough | From first dose until end of study, up to 36 months |
| Parts A, B, C: PK Characterization of AZD0486 | Derived PK Parameter: t1/2 | Pre-defined intervals from day 1 to day 28 |
| Parts A, B, C: PK Characterization of AZD0486 | Derived PK Parameter: CL of AZD0486 | From first dose until end of study, up to 36 months |
| Parts A, B, C: ADA characterization of AZD0486 | Summary of pre-existing and treatment-induced ADAs for AZD0486 (positive or negative, titres) | Consent until 36 months after first dose |
| Part C: Safety Evaluation of AZD0486 | Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in laboratory evaluations; QTc, and vital signs changes. | From signing of informed consent through completion of study treatment, an average of 8 months |
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