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

Prior treatment

• Expansion Phase:
  • \> 3 lines of prior systemic treatments
  • MSS colorectal cancer (CRC): liver metastasis present
• 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
• Current Grade \>2 toxicity related to prior anti-cancer therapy
• Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients
• Major surgery within defined period
• Allogenic tissue/solid organ transplant

Other illness

• Active infection requiring systemic therapy
• Impaired cardiac function or clinically significant cardiac disease
• History of drug-induced severe immune-related adverse reaction
• Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis
• 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

Other

• Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
• Pregnancy or breast-feeding
• Active untreated brain metastases

• Male or female aged ≥18 years
• Signed and dated informed consent form
• Measurable disease according to RECIST (Safety Expansion only)
• ECOG Performance status of 0 or 1
• Adequate organ and marrow function
• Escalation Phase: 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
• Expansion Phase: histologically and/or cytologically confirmed diagnosis of advanced PD-(L)1-naïve MSS colorectal cancer (CRC), PD-1 relapsed/refractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients, and that have measurable disease according to RECIST