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NCT06137118 · ClinicalTrials.gov registry record · Phase 1
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
A Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL), sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 163
- Enrollment target
- 20
- Study locations
NCT06137118: Recruiting Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL), sponsored by AstraZeneca.
NCT06137118 is a Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL) that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 163 participants, above the 106-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (54% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06137118, a Phase 1 study of B-cell Acute Lymphoblastic Leukemia (B-ALL), is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 163 participants
- Enrollment target
- 20
- Study locations
Study 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)
Primary Outcome
DLTs are dose-limiting toxicities as defined in the study protocol
Conditions Studied
Interventions
- DRUG AZD0486
Study Locations (20)
Other
- Research Site - Melbourne
- Research Site - Porto Alegre
- Research Site - São Paulo
- Research Site - São Paulo
- Research Site - Changsha
California
- Research Site - Duarte
- Research Site - Los Angeles
- Research Site - Palo Alto
Quebec
- Research Site - Montreal
- Research Site - Montreal
Alabama
- Research Site - Birmingham
Florida
- Research Site - Tampa
Georgia
- Research Site - Atlanta
Illinois
- Research Site - Chicago
New York
- Research Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2023-12-29 |
| Est. Completion | 2027-06-29 |
| Phase | Phase 1 |
What NCT06137118 shows while recruiting
NCT06137118 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, above the 106-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (54% higher).
The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia (B-ALL) appearing as the primary indexed condition, and to 1 intervention - of which AZD0486 is the first listed.
NCT06137118 names 20 study sites across 13 states, led by Other, California, Quebec.
Frequently Asked Questions
What is clinical trial NCT06137118 about?
NCT06137118 is a clinical study titled "AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia". 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...
What is the current status of trial NCT06137118?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 163 participants. The study started on 2023-12-29. Estimated completion is 2027-06-29.
What conditions does trial NCT06137118 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia (B-ALL).
What interventions are being tested in trial NCT06137118?
The interventions under investigation include: AZD0486 (DRUG).
Who is sponsoring clinical trial NCT06137118?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06137118 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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