First in human study to evaluate AZD9793 in participants with advanced or metastatic solid tumours - RHEA-1

Exclusion Criteria

• • Unresolved toxicity from prior anticancer therapy, including irAEs, 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 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 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.