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

• Status: Terminated
• Trial end date: 2020-09-14
• Target enrollment: 0
• Participant gender: All

Summary

This trial will study SGN-CD47M to find out whether it is an effective treatment for different types of solid tumors and what side effects (unwanted effects) may occur. The study will have two parts. Part A of the study will find out how much SGN-CD47M should be given for treatment and how often. Part B of the study will use the dose found in Part A and look at how safe and effective the treatment is.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.

Criteria

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