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Clinical Trials in the UK / NCT06137118
Recruiting Phase 1/2

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

NCT06137118 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 1/2
Started
2023-12-29
Last updated
2026-08-19

Condition(s) studied

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Investigational drug(s) / intervention(s)

Surovatamig

Surovatamig: Investigational Product administered via intravenous infusion.

Study summary

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimization study of surovatamig (AZD0486) to evaluate the safety, tolerability, and efficacy of surovatamig (AZD0486) monotherapy in participants with R/R B ALL. The study will consist of 4 parts. Part A: monotherapy dose escalation in 3L+ B-ALL. Part B: dose optimization in 3L+ B-ALL. Part C: Dose expansion in 3L+ B-ALL. Part D: Dose optimization and efficacy expansion in R/R B-ALL (2L+)

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age: 12 years and above (Parts A, B, C and D). * Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with: 1. Bone marrow infiltration with \>/= 5% blasts 2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option (Parts A, B, C); or relapsed or refractory to ≥1 prior line of therapy (Part D). 3. Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs. * For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS involvement. * 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. * History of other malignancy (with certain exceptions). * Unresolved AEs \>/= Grade 2, from prior therapies * Prior therapy with ADCs within 3 weeks, TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy. * GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment. The above is a summary, other exclusion criteria details may apply.

Primary outcome measure(s)

Trial sites (82)

FacilityCityRegionStatus
Research Site Birmingham Alabama Withdrawn
Research Site Duarte California Recruiting
Research Site Los Angeles California Recruiting
Research Site Palo Alto California Recruiting
Research Site Tampa Florida Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Chicago Illinois Recruiting
Research Site New York New York Recruiting
Research Site Houston Texas Recruiting
Research Site Richmond Virginia Recruiting
Research Site Seattle Washington Withdrawn
Research Site Milwaukee Wisconsin Recruiting
Research Site Melbourne Australia Withdrawn
Research Site Porto Alegre Brazil Suspended
Research Site São Paulo Brazil Suspended
Research Site São Paulo Brazil Suspended
Research Site Toronto Ontario Suspended
Research Site Montreal Quebec Withdrawn
Research Site Montreal Quebec Withdrawn
Research Site Changsha China Recruiting
Research Site Chengdu China Recruiting
Research Site Guangzhou China Recruiting
Research Site Guangzhou China Recruiting
Research Site Hangzhou China Recruiting
Research Site Nanjing China Recruiting
Research Site Nanjing China Recruiting
Research Site Suzhou China Recruiting
Research Site Tianjin China Recruiting
Research Site Zhengzhou China Recruiting
Research Site Caen France Suspended
Research Site Marseille France Suspended
Research Site Nantes France Suspended
Research Site Paris France Suspended
Research Site Pierre-Bénite France Suspended
Research Site Toulouse France Suspended
Research Site Berlin Germany Not Yet Recruiting
Research Site Cologne Germany Suspended
Research Site Düsseldorf Germany Suspended
Research Site Essen Germany Withdrawn
Research Site Frankfurt Germany Suspended

+ 42 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06137118 on ClinicalTrials.gov ↗ ← All trials in the UK