hepatocellular carcinoma
Conditions
Interventions
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age 18 or more 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. -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 who have received at least one prior line of standard systemic therapy for HCC as per NCCN or other local scientific guidelines and for which a clinical study is the best option for next treatment based on prior response and/or tolerability and/or patient/investigator decision. Part B: Patients must not have received more than 1 prior line of systemic therapy in the advanced recurrent and/or metastatic setting.
Exclusion criteria
Exclusion criteria: -Unresolved toxicity from prior anticancer therapy, including irAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or more except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities. -Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter. -CAR-T cell therapy within the last 6 months prior to enrolment on this study. -Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB. -Requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent). -Prior treatment with any therapy that is targeted to GPC3. -Received any therapy to treat cancer (including chemotherapy, biologics, cellular therapies) within 5 half-lives of an anticancer drug prior to the first dose of study treatment. -Received radiation within 14 days; palliative radiation to reduce the risk of tumour lysis syndrome (TLS) or CRS/neurotoxicity in participants with bulky disease is permitted. -Undergone a major surgical procedure within 14 days to allow adequate healing. -Experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy. -Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS). -Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment. - Cardiac conditions as defined by the protocol. -History of thromboembolic event within the past 3 months prior to the scheduled first
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -The number of patients with adverse events [Time Frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy] : Number of patients with adverse events by system organ class and preferred term -The number of patients with serious adverse events [Time Frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy] : Number of patients with serious adverse events by system organ class and preferred term -The number of patients with adverse events of special interest [Time Frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy] : Number of patients with adverse events of special interest by system organ class and preferred term -The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. [Time Frame: From date of first dose of study drug until the end of Cycle 1 (up to 28 days)] : Number of patients with at least 1 DLT. A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. -Objective Response Rate (ORR) [Dose expansion only / Time Frame: From first dose of study drug to progressive disease or the last evaluable assessment in the absence of disease progression whichever comes first (up to approximately 2 years)] : The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose expansion only. | — |
Countries
China, Hong Kong, Japan, South Korea, Spain, Taiwan, United States
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed