Active — Not RecruitingPhase 1/2

A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma

United States94 participantsStarted 2023-12-14

Plain-language summary

A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. Participant must be 18 years or older and has voluntarily agreed to participate by giving written informed consent.
✓. Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings
✓. Completed or were unable to tolerate at least one prior line of standard systemic therapy for HCC and/or participant/investigator decision.
✓. GPC3-positive tumour as determined by a central laboratory using an analytically validated IHC assay
✓. Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis
✓. Child-Pugh score: Grade A
✓. Participants with HBV and HCV undergoing management of these infections per institutional practice.

Exclusion criteria

✕. Active or prior documented gastrointestinal (GI) variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 12 months
✕. History of liver transplantation or on waiting list
✕. Current clinically significant ascites
✕. Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava
✕. Uncontrolled intercurrent illness
✕. Active Infections
✕. Positive serology for HIV
✕. History of hepatic encephalopathy within 12 months prior to treatment allocation

What they're measuring

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

Timeframe: Through study completion, an average of 2 years

Trial details

NCT IDNCT06084884

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-13

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