Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

Inclusion Criteria: Male or female aged ≥18 years Signed and dated informed consent form Histologically and/or cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists Measurable disease according to RECIST (Safety Expansion only) ECOG Performance status of 0 or 1 Adequate organ and marrow function Exclusion Criteria: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC) Pregnancy or breast-feeding Prior treatment with or receipt of: biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805 chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C. anti-SIRPα or anti-CD47-directed therapy systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805 other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805 vaccine containing live virus within 28 prior to the first dose of ADU-1805 Active untreated brain metastases Active infection requiring systemic therapy Impaired cardiac function or clinically significant cardiac disease Current Grade >2 toxicity related to prior anti-cancer therapy History of drug-induced severe immune-related adverse reaction Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients Major surgery within defined period Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis Allogenic tissue/solid organ transplant Any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study