A Study to Evaluate the Safety and Tolerability of EP0089

Inclusion criteria

Applicable to all patients:

• Must be ≥18 years of age (≥19 in South Korea) with documented recurrent, metastatic or unresectable solid tumours for whom no standard therapy exists or standard therapy has failed
• ECOG performance status of 0 or 1 and life expectancy >3 months at screening
• Ability to understand and provide written informed consent
• Must be willing to comply with necessary contraceptive methods as required
• Willing and able to comply with the scheduled study treatment plan, laboratory tests, and other study procedures.
• Adequate hepatic, haematological and renal function as assessed by protocol-defined criteria.
• Additional cohort/disease specific criteria apply
• Measurable disease per RECIST v1.1

Exclusion criteria

• Known active CNS metastases and/or leptomeningeal disease and/or carcinomatous meningitis.
• Recent major surgery
• Recent live or live-attenuated vaccine ≤ 30 days prior to the first dose
• Current active, or history of, autoimmune disease that requires or required systemic treatment (ie, with disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to starting study treatment.
• Prior severe hypersensitivity reaction to mAbs
• Previous > Grade 2 peripheral neuropathy.
• Significant neurological condition eg stroke, transient ischaemic attack (in the last 12 months), epilepsy, head trauma, brain surgery or prior history of any significant psychiatric disorder

• Current active, or history of, autoimmune disease that requires or required continuous treatment within 2 years prior to starting study treatment

• Receiving chronic systemic steroid therapy (> 10 mg /day of prednisone or equivalent) or any other form of immunosuppressive therapy ≤ 7 days prior the first dose of study drug. Topical or inhaled steroids are permitted.

• Any prior immune-mediated or immune-related adverse events related to treatment with immune-modulatory agents that caused permanent discontinuation of the agent, that were ≥ Grade 3 in severity or in the opinion of the Investigator would otherwise jeopardise patient safety in this study.

• One or more clinically significant (ie, active) cardiovascular diseases, myocardial infarction, or unstable angina (≤ 6 months prior to first administration of study drug)