First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours
Trial Parameters
Brief Summary
This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.
Eligibility Criteria
Key Inclusion Criteria: * Age ≥ 18 at the time of signing the informed consent. * GPC3 positive tumour as determined by a central laboratory using an analytically validated IHC assay. * Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening. * Predicted life expectancy of ≥ 12 weeks. * Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol. * Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol. * Confirmed advanced recurrent and/or metastatic and/or unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization. * Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C. * Child-Pugh Score class A. * Previous therapy: Part A: Patients