First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours

Exclusion Criteria16

• Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 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 radiation within 14 days prior to first dose of study treatment; 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 prior to first dose of study treatment 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 dose of study intervention.
• Central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent.
• Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.
• Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma.