AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06137118
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia (B-ALL)

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surovatamig — DRUG
    Investigational Product administered via intravenous infusion.

Study Details

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+)

Key Dates

First listed
Nov 18, 2023
Start date
Dec 29, 2023
Status verified
Aug 2026
Primary completion
Feb 11, 2028
Completion
Sep 15, 2028

Study Design

Enrollment
255 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: AZD0486 Dose Escalation
    Ascending dose level cohorts of surovatamig (AZD0486) in B-ALL participants aged 12 years and above.
  • Experimental: Part B: Dose Optimization
    Up to 2 cohorts will be evaluated prior declared safe-doses and schedules in order to determine the recommended phase 2 dose (RP2D). Participants, aged 12 years and above, will receive surovatamig (AZD0486) IV infusions and will be randomized in a 1:1 ratio.
  • Experimental: Part C: Dose Expansion
    Part C will consist of 1 cohort of participants aged 12 years and above, treated with the optimal dose selected in Part B and receive IV surovatamig (AZD0486) monotherapy.
  • Experimental: Part D: Dose Optimization and Efficacy Expansion in 2L+
    Part D will enroll participants aged 12 years and above with Ph(+) and Ph(-) B-ALL relapsed/refractory to ≥1 prior line of therapy. Participants will be randomized 1:1 to 2 dose levels of surovatamig IV.

Primary Outcome Measure

Part A: Frequency of DLTs [ Time Frame: Up to 28 days ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35205-
Research SiteDuarteCalifornia91010-
Research SiteLos AngelesCalifornia90048-
Research SitePalo AltoCalifornia94304-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60637-
Research SiteNew YorkNew York10016-
Research SiteHoustonTexas77030-
Research SiteRichmondVirginia23298-
Research SiteSeattleWashington98109-
Research SiteMilwaukeeWisconsin53226-

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