AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Study acronym: SYRUS
StatusRecruiting
PhasePhase 1/2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later across 2 updates Nov 13, 2026 → Jan 6, 2028
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from AstraZeneca

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 3 of 4 entries Show 6 more changesShow less
    • Primary completion moved earlier from Feb 11, 2028 to Jan 6, 2028
    • Study completion moved earlier from Sep 15, 2028 to Aug 10, 2028
    • Study sites: 82 to 83
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 12 of 17 entries
    • Publications: details revised at 1 of 1 entry
  2. Primary completion pushed from Nov 13, 2026 to Feb 11, 2028v19 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Study completion pushed from Jun 29, 2027 to Sep 15, 2028
    • Trial arms changed: 3 → 4
    • Enrollment target: 236 to 255
    • Study sites: 80 to 82
    • Interventions: AZD0486 (Drug) to Surovatamig (Drug)
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 16 to 17
    • Study description expanded, about 1 word
  3. Enrollment increased: 163 → 236 participants
    • Site details revised at 39 of 80 sites
    v18
  4. Study sites: 79 to 80v17
  5. Enrollment target: 142 to 163
    • Site details revised at 10 of 79 sites
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Re-verified, no change to tracked fieldsv15
  2. Study sites: 71 to 79v14
  3. Primary endpoints revised (3)v13 Show 6 more changesShow less
    • Enrollment target: 120 to 142
    • Study sites: 64 to 71
    • Primary completion date: Jul 31, 2026 to Nov 13, 2026
    • Study completion date: May 18, 2027 to Jun 29, 2027
    • Secondary endpoints: 15 to 16
    • Eligibility criteria expanded, about 3 words
  4. Study sites: 62 to 64v12 Show 4 more changesShow less
    • Primary completion date: Jun 30, 2026 to Jul 31, 2026
    • Study completion date: Jun 29, 2027 to May 18, 2027
    • Secondary endpoints revised (15)
    • Eligibility criteria shortened, about 5 words
  5. Study sites: 60 to 62v11
  6. Site details revised at 4 of 60 sitesv10
  7. Study sites: 58 to 60v9
  8. Study sites: 55 to 58
    • Primary completion date: Jan 29, 2026 to Jun 30, 2026
    • Study completion date: Feb 4, 2027 to Jun 29, 2027
    v8
  9. Site details revised at 13 of 55 sitesv7
  10. Primary endpoints revised (3)v6 Show 4 more changesShow less
    • Study sites: 53 to 55
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 14 to 15
    • Study description expanded, about 22 words
  11. Study sites: 44 to 53v5
  12. Study sites: 41 to 44v4
  13. Study sites: 38 to 41v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 31 to 38
    • Start date changed from estimate of Dec 26, 2023 to Dec 29, 2023
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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+)
Trial Details
NCT Number NCT06137118
Lead Sponsor AstraZeneca
Conditions
(from sponsor)		 B-cell Acute Lymphoblastic Leukemia (B-ALL)
Related terms Burkitt Lymphoma, Leukemia
Enrollment 255 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov