Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT07109219
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

  • AZD4512 monotherapy — COMBINATION_PRODUCT
    Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22

Study Details

The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).

Key Dates

Start date
Nov 12, 2025
Status verified
Jun 2026
Primary completion
Apr 28, 2028
Completion
Jul 3, 2028

Study Design

Enrollment
83 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 Dose Escalation
    Module 1 will evaluate escalating doses of AZD4512 as monotherapy to determine the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in Module 2 (dose optimization), in participants with relapsed/refractory (R/R) Philadelphia chromosome positive (Ph\[+\]) and negative (Ph\[-\]) B-ALL, R/R as defined by National Comprehensive Cancer Network (NCCN) guidelines.
  • Experimental: Module 2 Dose Optimization
    Module 2 will randomize participants with R/R (as defined by NCCN guidelines) Ph(-) BALL only across 2 to 3 dose levels identified in Module 1 to receive AZD4512 monotherapy for further exploration of the doses. The aim of Module 2 is to identify the recommended Phase 2 dose (RP2D) of AZD4512 monotherapy, evaluate the efficacy and further define the safety profile of AZD4512.

Primary Outcome Measure

Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs). [ Time Frame: From first dose up to 21 days (DLT period). ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteJacksonvilleFlorida32224-
Research SiteChicagoIllinois60611-
Research SiteIowa CityIowa52242-
Research SiteFranklinTennessee37067-
Research SiteHoustonTexas77030-

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By research site
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