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

Status
Active
Cancer Type
Liver Cancer / Hepatoblastoma
Trial Phase
Phase I
Phase II
Eligibility
18 - 130 Years, Male and Female
Study Type
Treatment
NCT ID
NCT06084884
Protocol IDs
D7670C00001 (primary)
NCI-2023-10232
Study Sponsor
AstraZeneca Pharmaceuticals LP

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

  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 tolerate at least one prior line of standard systemic therapy for HCC and/or participant/investigator decision.
  4. GPC3-positive tumour as determined by a central laboratory using an analytically validated IHC assay
  5. Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis
  6. Child-Pugh score: Grade A
  7. Participants with HBV and HCV undergoing management of these infections per institutional practice.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.