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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03957096
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : May 21, 2019
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Colorectal Cancer Head and Neck Squamous Cell Carcinoma Non-small Cell Lung Carcinoma Breast Carcinoma Ovarian Carcinoma Exocrine Pancreatic Carcinoma Gastric Carcinoma Melanoma Drug: SGN-CD47M Phase 1

Detailed Description:

This is a dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SGN-CD47M in adults with advanced solid tumors. The study will be conducted in 2 parts:

Part A - Dose escalation: Up to approximately 25 patients will be treated to evaluate the safety, tolerability, and PK of SGN-CD47M, and to identify the maximum tolerated dose (MTD) and/or optimal dose.

Part B - Dose expansion: Up to approximately 180 patients will be treated in expansion cohorts at the MTD or optimal dose to further characterize the safety, PK, and antitumor activity of SGN-CD47M.

In eligible patients, standard therapies must have failed, been intolerable, or been considered medically inappropriate by the investigator. If the MTD is not reached in Part A, safety, PK, pharmacodynamic, and biomarker analyses, as well as preliminary antitumor activity, will be used to determine the optimal dose. Patients in Part A may continue on treatment until confirmed progressive disease (PD) or unacceptable toxicity, whichever occurs first. The dose(s) to be examined in Part B will be at or below the MTD and/or the optimal dose determined in Part A.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors
Actual Study Start Date : July 17, 2019
Actual Primary Completion Date : September 14, 2020
Actual Study Completion Date : September 14, 2020


Arm Intervention/treatment
Experimental: SGN-CD47M Drug: SGN-CD47M
SGN-CD47M administered intravenously




Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Up to approximately 24 months ]
  2. Number of patients with laboratory abnormalities [ Time Frame: Up to approximately 24 months ]
  3. Number of patients with dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) per RECIST v1.1 [ Time Frame: Up to approximately 2.5 years ]
    Defined as the proportion of patients with CR or PR

  2. ORR per iRECIST [ Time Frame: Up to approximately 2.5 years ]
    Defined as the proportion of patients with iCR or iPR

  3. Duration of objective response (DOR) per RECIST v1.1 [ Time Frame: Up to approximately 2.5 years ]
    Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever comes first

  4. DOR per iRECIST [ Time Frame: Up to approximately 2.5 years ]
  5. Duration of complete response (CR) per RECIST v1.1 [ Time Frame: Up to approximately 2.5 years ]
    Defined as the time from start of the first documentation of objective tumor response to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first for the subgroup of patients achieving a CR

  6. Duration of CR per iRECIST [ Time Frame: Up to approximately 2.5 years ]
  7. Progression-free survival (PFS) per RECIST v1.1 [ Time Frame: Up to approximately 2.5 years ]
    Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first

  8. PFS per iRECIST [ Time Frame: Up to approximately 2.5 years ]
  9. Overall survival (OS) [ Time Frame: Up to approximately 4 years ]
    Defined as the time from the start of any study treatment to the date of death due to any cause

  10. Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 24 months ]
  11. Maximum concentration (Cmax) [ Time Frame: Up to approximately 24 months ]
  12. Time to Cmax (Tmax) [ Time Frame: Up to approximately 24 months ]
  13. Trough concentration (Ctrough) [ Time Frame: Up to approximately 24 months ]
  14. Incidence of antidrug antibodies (ADA) [ Time Frame: Up to approximately 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957096


Locations
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United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Tennessee
Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4095
NEXT Oncology
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Michael Schmitt, MD, PhD Seagen Inc.
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT03957096    
Other Study ID Numbers: SGN47M-001
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
HNSCC
NSCLC
Additional relevant MeSH terms:
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Carcinoma
Sarcoma
Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Carcinoma, Squamous Cell
Neoplasms, Connective and Soft Tissue
Breast Diseases
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Head and Neck Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Pancreatic Diseases