A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD4512: AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion
Study summary
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).
Eligibility
Primary outcome measure(s)
- Percentage of participants with dose-limiting toxicities (DLTs) — Up to 4 weeks
To identify the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in participants with R/R B-NHL - Frequency, duration, severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) — From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL - Frequency of SAEs/AEs leading to discontinuation of AZD4512 — From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL - Number of participants with clinically significant alterations in vitals signs and abnormal laboratory parameters — From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Irvine | California | Suspended |
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Rochester | Minnesota | Recruiting |
| Research Site | New York | New York | Suspended |
| Research Site | New York | New York | Recruiting |
| Research Site | Cleveland | Ohio | Withdrawn |
| Research Site | Myrtle Beach | South Carolina | Withdrawn |
| Research Site | Franklin | Tennessee | Recruiting |
| Research Site | Macquarie University | Australia | Not Yet Recruiting |
| Research Site | Melbourne | Australia | Recruiting |
| Research Site | Chengdu | China | Not Yet Recruiting |
| Research Site | Guangzhou | China | Not Yet Recruiting |
| Research Site | Bologna | Italy | Recruiting |
| Research Site | Milan | Italy | Recruiting |
| Research Site | Milan | Italy | Recruiting |
| Research Site | Bunkyō City | Japan | Recruiting |
| Research Site | Kōtoku | Japan | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Taichung | Taiwan | Recruiting |
| Research Site | Taipei | Taiwan | Recruiting |
| Research Site | London | United Kingdom | Recruiting |
| Research Site | Newcastle upon Tyne | United Kingdom | Recruiting |
More AstraZeneca trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07123454 on ClinicalTrials.gov ↗ ← All trials in South Korea