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

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ClinicalTrials.gov Identifier: NCT03957096
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, 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 1 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)
Estimated Enrollment : 205 participants
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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022


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. Best response per iRECIST [ Time Frame: Up to approximately 30 months ]
    Defined as the proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) per iRECIST

  2. Objective response rate (ORR) [ Time Frame: Up to approximately 2.5 years ]
    Defined as the proportion of patients with CR or PR

  3. Duration of objective response (DOR) [ 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 confirmed tumor progression or to death due to any cause, whichever comes first

  4. Duration of complete response [ 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

  5. Progression-free survival (PFS) [ Time Frame: Up to approximately 2.5 years ]
    Defined as the time from start of study treatment to first documentation of confirmed tumor progression or to death due to any cause, whichever comes first

  6. 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

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


Information from the National Library of Medicine

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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
  • Tumor site accessible for biopsy
  • 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


Contacts
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Dominque McReynolds    210-580-9517    dmcreynolds@nextoncology.com   
Contact: Kayla Dotson    210-580-9515    kdotson@nextoncology.com   
Principal Investigator: Anthony Tolcher, MD, Medical Oncology         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Michael Schmitt, MD, PhD Seattle Genetics, Inc.

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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03957096     History of Changes
Other Study ID Numbers: SGN47M-001
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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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 Seattle Genetics, Inc.:
HNSCC
NSCLC

Additional relevant MeSH terms:
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Carcinoma
Colorectal Neoplasms
Carcinoma, Squamous Cell
Sarcoma
Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Pancreatic Neoplasms
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Squamous Cell
Neoplasms, Connective and Soft Tissue
Breast Diseases
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms