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:

  1. Soft tissue sarcoma
  2. Colorectal carcinoma
  3. Non-small cell lung carcinoma
  4. Head and neck squamous cell carcinoma
  5. Breast carcinoma
  6. Ovarian carcinoma
  7. Exocrine pancreatic adenocarcinoma
  8. Gastric carcinoma
  9. 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