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Also known as Cell Therapy
AZD5851 · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| AZD5851 | EXPERIMENTAL | Subjects will receive AZD5851 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). |
| Name | Type | Description |
|---|---|---|
| AZD5851 | BIOLOGICAL | 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. |
Inclusion Criteria: 1. Participant must be 18 years or older and has voluntarily agreed to participate by giving written informed consent. 2. Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings 3. Completed or were unable to toler...
AZD5851 is an investigational therapy being studied for the treatment of advanced or recurrent hepatocellular carcinoma, a type of liver cancer. It is specifically being evaluated in patients whose tumors are GPC3-positive, meaning the cancer cells express the GPC3 protein. AZD5851 is not yet approved for any indication and remains in clinical development.
AZD5851 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this monoclonal antibody in hepatocellular carcinoma.
AZD5851 is in Phase 1 clinical development. The ongoing study is a Phase I/II trial, and the drug has not yet advanced to later-stage testing. It is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.
AZD5851 is being evaluated in a single active clinical trial, NCT06084884, titled a Phase I/II study of AZD5851 in GPC3-positive advanced or recurrent hepatocellular carcinoma. The trial is currently active but not recruiting, with an estimated enrollment of 94 participants across the United States, Japan, and South Korea.
No, AZD5851 is not FDA approved. It is an investigational monoclonal antibody still in Phase 1 clinical development for hepatocellular carcinoma. Approval status has not been granted, and the drug remains available only through clinical trial participation.