A Safety Study of SGN-CD47M in Patients With Solid Tumors

Inclusion Criteria

• Histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the following indications:
• Soft tissue sarcoma
• Colorectal carcinoma
• Non-small cell lung carcinoma
• Head and neck squamous cell carcinoma
• Breast carcinoma
• Ovarian carcinoma
• Exocrine pancreatic adenocarcinoma
• Gastric carcinoma
• Melanoma
• Relapsed, refractory, or progressive disease with no appropriate standard therapy available at the time of enrollment
• ECOG performance status of 0 or 1
• Measureable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline
• Patients of childbearing potential may not be pregnant, must agree not to become pregnant until at 30 days after last dose of study drug, and must use 2 effective means of birth control.
• Patients who can father children must use 2 effective means of birth control and must agree not to donate sperm until at least 60 days after last dose of study drug.

Exclusion Criteria

• History of another malignancy within 3 years prior to first dose of study drug (exceptions for malignancies with negligible risk of metastasis)
• Previous exposure to CD47 or SIRPα targeted therapy
• Chemotherapy, systemic radiotherapy, biologics, other anti-neoplastic or investigational agents, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of SGN-CD47M. Focal radiotherapy that is not completed 2 weeks prior to the first dose of SGN-CD47M
• Known active central nervous system metastases
• Positive for hepatitis B, active hepatitis C infections, positive for human immunodeficiency virus (HIV), or known active or latent tuberculosis
• History of sickle cell anemia, auto-immune hemolytic anemia, or idiopathic thrombocytopenic purpura
• Carcinomatous meningitis
• Red blood cell transfusion within 4 weeks prior to enrollment or platelet transfusion within 2 weeks prior to enrollment
• Any active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose
• History of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to first dose
• Condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 2 week prior to first dose
• Active autoimmune disease, autoimmune-related toxicity from prior immuno-oncology-based therapy
• Estimated life expectancy of less than 12 weeks