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