A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
Liver Cancer / Hepatoblastoma
18 - 130 Years, Male and Female
D7670C00001 (primary)
NCI-2023-10232
Summary
A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent
hepatocellular carcinoma.
Objectives
This first-time in human, single-arm, open-label multicentre Phase I/II study will
evaluate the safety, tolerability, antitumour activity, cellular kinetics,
pharmacodynamics, and immunogenicity of AZD5851 in adult participants with GPC3+
advanced/recurrent HCC, where at least one line of prior therapy has failed/or was
intolerable, or participant/investigator decision.
Eligibility
- 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.
Treatment Sites in Georgia
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