A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
NCT ID: NCT07123454
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
91 participants
INTERVENTIONAL
2025-09-24
2028-03-01
Brief Summary
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Detailed Description
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Additional modules in specific B-NHL subtypes with AZD4512 as monotherapy or in combination with other anticancer agent(s) may be added in the future
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
\- Module 1: AZD4512 Monotherapy.
TREATMENT
NONE
Study Groups
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Module 1: AZD4512 Monotherapy dose escalation + backfill
In Mod 1, the efficacy and safety of AZD4512 will be evaluated in R/R B-NHL. Module 1 will consist of both dose escalation and Pharmacodynamic/safety backfills which may be used to support MTD and/or Optimal biological dose (OBD)
AZD4512
AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion
Interventions
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AZD4512
AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion
Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per World Health Organization (WHO) 2021 classification. In the dose escalation phase, any B-NHL subtype is allowed (excluding some subtypes), while the backfill phase restricts inclusion to defined subtypes: large B-cell lymphomas (as defined as Diffuse large B-cell lymphoma (DLBCL), Grade 3b Follicular lymphoma (FL), double/triple hit lymphomas, high-grade (B-cell lymphoma) BCL, primary mediastinal Large B-cell lymphoma (LBCL), and transformed indolent lymphoma), mantle cell lymphoma, and follicular lymphoma grades 1-3a.
* Patients must have relapsed or refractory disease after at least two prior lines of therapy and lack additional standard options with survival benefit:
A)LBCL patients must have progressed after both anti-CD20 and at least one systemic chemotherapy regimen, and have considered-or be ineligible for-CAR-T, T cell engager, and stem cell transplant modalities.
B) Mantle cell lymphoma (MCL) patients must have had anti-CD20 and Bruton's Tyrosine Kinase (BTK) inhibitor.
C)FL patients should have failed anti-CD20 with active disease requiring therapy.
Additional criteria include measurable disease by Lugano 2014, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and adequate organ and bone marrow function (as specified by blood counts, cardiac ejection fraction, renal and hepatic parameters, and coagulation indices).
Exclusion Criteria
* Other exclusions include allogeneic Hematopoietic stem cell transplantation (HSCT) within 180 days (unless stable without active (graft-versus-host disease) GVHD for ≥2 months), autologous HSCT within 90 days (unless resolved toxicities), major surgery within 28 days, use of strong CYP3A4 inhibitors or (corrected QT interval - prolonging agents at C1, or other malignancies within two years. Patients with unresolved ≥ Grade 2 AEs from prior therapy (except specified tolerable conditions), serious uncontrolled medical conditions, active infection within 14 days, or history/suspicion of significant interstitial lung disease/pneumonitis are also excluded.
* Females who are pregnant or breastfeeding are not eligible.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Irvine, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Rochester, Minnesota, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Franklin, Tennessee, United States
Research Site
Melbourne, , Australia
Research Site
Chengdu, , China
Research Site
Guangzhou, , China
Research Site
Bologna, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Bunkyō City, , Japan
Research Site
Kōtoku, , Japan
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
London, , United Kingdom
Research Site
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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D9890C00001
Identifier Type: -
Identifier Source: org_study_id