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AZD5851

Phase 1

Hepatocellular Carcinoma | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06084884A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular CarcinomaPHASE1 ACTIVE NOT_RECRUITING 94 — — Dec 14, 2023Dec 13, 2027May 22, 202618 United States, Japan +1
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Study Endpoints
Primary Endpoints
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

Secondary Endpoints
1. Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR)
Through study completion, an average of 2 years
2. Interval between the date of AZD5851 infusion dose and first documented evidence of CR or PR
Through study completion, an average of 2 years
3. Proportion of participants who have a confirmed CR, PR, or who have stable disease (SD) for at least 5 weeks after the date of AZD5851 infusion
Through study completion, an average of 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD5851EXPERIMENTALSubjects will receive AZD5851 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).
Interventions
NameTypeDescription
AZD5851BIOLOGICALSubjects 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.
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites18

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...

Countries:United StatesJapanSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06084884primaryCompletionDate: changed
LOWMay 24, 2026NCT06084884studyFirstPostDate: changed