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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.

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date September 17, 2020
Actual Study Start Date  ICMJE July 17, 2019
Actual Primary Completion Date September 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • Number of patients with adverse events [ Time Frame: Up to approximately 24 months ]
  • Number of patients with laboratory abnormalities [ Time Frame: Up to approximately 24 months ]
  • Number of patients with dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2020)
  • 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
  • ORR per iRECIST [ Time Frame: Up to approximately 2.5 years ]
    Defined as the proportion of patients with iCR or iPR
  • 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
  • DOR per iRECIST [ Time Frame: Up to approximately 2.5 years ]
  • 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
  • Duration of CR per iRECIST [ Time Frame: Up to approximately 2.5 years ]
  • 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
  • PFS per iRECIST [ Time Frame: Up to approximately 2.5 years ]
  • 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
  • Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 24 months ]
  • Maximum concentration (Cmax) [ Time Frame: Up to approximately 24 months ]
  • Time to Cmax (Tmax) [ Time Frame: Up to approximately 24 months ]
  • Trough concentration (Ctrough) [ Time Frame: Up to approximately 24 months ]
  • Incidence of antidrug antibodies (ADA) [ Time Frame: Up to approximately 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • 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
  • Objective response rate (ORR) [ Time Frame: Up to approximately 2.5 years ]
    Defined as the proportion of patients with CR or PR
  • 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
  • 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
  • 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
  • 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
  • Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 24 months ]
  • Maximum concentration (Cmax) [ Time Frame: Up to approximately 24 months ]
  • Time to Cmax (Tmax) [ Time Frame: Up to approximately 24 months ]
  • Trough concentration (Ctrough) [ Time Frame: Up to approximately 24 months ]
  • Incidence of antidrug antibodies (ADA) [ Time Frame: Up to approximately 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of SGN-CD47M in Patients With Solid Tumors
Official Title  ICMJE A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: SGN-CD47M
SGN-CD47M administered intravenously
Study Arms  ICMJE Experimental: SGN-CD47M
Intervention: Drug: SGN-CD47M
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 15, 2020)
16
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2019)
205
Actual Study Completion Date  ICMJE September 14, 2020
Actual Primary Completion Date September 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957096
Other Study ID Numbers  ICMJE SGN47M-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seagen Inc.
Study Sponsor  ICMJE Seagen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Schmitt, MD, PhD Seagen Inc.
PRS Account Seagen Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP