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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 monoclonal antibody being developed for the treatment of GPC3-positive advanced or recurrent hepatocellular carcinoma, a type of liver cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AZD5851 targets GPC3, a protein that is overexpressed in hepatocellular carcinoma cells. By binding to GPC3, the monoclonal antibody is designed to direct the immune system to attack and destroy cancer cells that express this protein.
AZD5851 is being developed by AstraZeneca PLC, a global biopharmaceutical company listed on the NASDAQ under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.
AZD5851 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies and is still being studied in clinical trials to assess its safety and effectiveness.
AZD5851 is being evaluated in a Phase I/II study (NCT06084884) for GPC3-positive advanced or recurrent hepatocellular carcinoma. This active, non-recruiting trial has an enrollment of 94 participants and is being conducted in the United States, Japan, and South Korea.