Otwarte, wieloośrodkowe, wieloramienne badanie fazy 1 oceniające bezpieczeństwo i farmakokinetykę ADU-1805 u dorosłych z zaawansowanymi guzami litymi

Kryteria wyłączenia kto nie może wziąć udziału (22)

1. Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
2. Expansion Phase:
3. > 3 lines of prior systemic treatments
4. MSS colorectal cancer (CRC): liver metastasis present
5. Pregnancy or breast-feeding
6. Prior treatment with or receipt of:
7. biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805
8. 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.
9. anti-SIRPα or anti-CD47-directed therapy
10. systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805
11. other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805
12. vaccine containing live virus within 28 prior to the first dose of ADU-1805
13. Active untreated brain metastases
14. Active infection requiring systemic therapy
15. Impaired cardiac function or clinically significant cardiac disease
16. Current Grade >2 toxicity related to prior anti-cancer therapy
17. History of drug-induced severe immune-related adverse reaction
18. Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients
19. Major surgery within defined period
20. Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis
21. Allogenic tissue/solid organ transplant
22. 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