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NCT06137118 · ClinicalTrials.gov record · last posted 2026-08-19

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Study acronym: SYRUS
StatusRecruiting
PhasePhase 1/2
Started2023-12-29
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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+)

Protocol amendment history 5 changes detected by DataLookout

2026-08-20
Primary endpoint(s) modified
WasPart A: Frequency of DLTs, Parts A & B: Safety Evaluation of AZD0486, Parts B & C: Rate of CR within 3 cycles
NowPart A: Frequency of DLTs, Part D: CR/CRh within 3 cycles, Parts A & B: Safety Evaluation of AZD0486, Parts B & C: Rate of CR within 3 cycles
2026-08-20
Trial arms changed: 3 → 4
2026-08-20
Primary completion pushed: 2026-11-13 → 2028-02-11
2026-08-20
Completion pushed: 2027-06-29 → 2028-09-15
2026-05-28
Enrollment increased: 163 → 236 participants
Trial Details
NCT Number NCT06137118
Lead Sponsor AstraZeneca
Conditions B-cell Acute Lymphoblastic Leukemia (B-ALL)
Enrollment 255 participants
Start Date 2023-12-29
Primary Completion 2028-02-11 (estimated)
Study Completion 2028-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-19