A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Irvine, California.

Sponsor
AstraZeneca
Study ID
NCT07123454
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • AZD4512 — DRUG
    AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion

Study Details

This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).

Key Dates

First listed
Aug 14, 2025
Start date
Sep 24, 2025
Status verified
Jun 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

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

Arms

  • Experimental: 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)

Primary Outcome Measure

Percentage of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteIrvineCalifornia92618-
Research SiteJacksonvilleFlorida32224-
Research SiteRochesterMinnesota55905-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10021-
Research SiteClevelandOhio44195-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteFranklinTennessee37067-

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