Study Stopped
Sponsor decision based on portfolio prioritization
A Safety Study of SGN-CD47M in Patients With Solid Tumors
A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors
1 other identifier
interventional
16
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2019
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
July 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2020
CompletedSeptember 17, 2020
September 1, 2020
1.2 years
May 17, 2019
September 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of patients with adverse events
Up to approximately 24 months
Number of patients with laboratory abnormalities
Up to approximately 24 months
Number of patients with dose-limiting toxicities (DLTs)
28 days
Secondary Outcomes (14)
Objective response rate (ORR) per RECIST v1.1
Up to approximately 2.5 years
ORR per iRECIST
Up to approximately 2.5 years
Duration of objective response (DOR) per RECIST v1.1
Up to approximately 2.5 years
DOR per iRECIST
Up to approximately 2.5 years
Duration of complete response (CR) per RECIST v1.1
Up to approximately 2.5 years
- +9 more secondary outcomes
Study Arms (1)
SGN-CD47M
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (5)
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Schmitt, MD, PhD
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 21, 2019
Study Start
July 17, 2019
Primary Completion
September 14, 2020
Study Completion
September 14, 2020
Last Updated
September 17, 2020
Record last verified: 2020-09