A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD5851: Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce AZD5851. During AZD5851 production, subjects may receive bridging therapy for disease control. Upon successful generation of AZD5851 product, subjects will receive treatment with AZD5851 therapy. Study treatment will include lymphodepleting chemotherapy followed by one dose of AZD5851 administered by intravenous (IV) infusion.
Study summary
A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
Eligibility
Primary outcome measure(s)
- 1. Incidence of participants with dose-limiting toxicities (DLTs), adverse events (AEs), including adverse events of special interest (AESI) and serious adverse events (SAEs). Determination of the recommended dose of AZD5851 for expansion phase — Through study completion, an average of 2 years
Determine if treatment with AZD5851 is safe and tolerable through assessment of DLTs, AEs, SAEs and changes from baseline in vital signs, ECGs, and laboratory parameters
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Phoenix | Arizona | |
| Research Site | Duarte | California | |
| Research Site | Los Angeles | California | |
| Research Site | Orange | California | |
| Research Site | San Francisco | California | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Jacksonville | Florida | |
| Research Site | Atlanta | Georgia | |
| Research Site | Westwood | Kansas | |
| Research Site | Rochester | Minnesota | |
| Research Site | Hackensack | New Jersey | |
| Research Site | New York | New York | |
| Research Site | Columbus | Ohio | |
| Research Site | Portland | Oregon | |
| Research Site | Philadelphia | Pennsylvania | |
| Research Site | Pittsburgh | Pennsylvania | |
| Research Site | Kashiwa | Japan | |
| Research Site | Osakasayama-shi | Japan | |
| Research Site | Seoul | South Korea |
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 NCT06084884 on ClinicalTrials.gov ↗ ← All trials in South Korea