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A Study of SGN-B6A in Advanced 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389632
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:

This trial will look at a drug called SGN-B6A to find out whether it is safe for people who have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-B6A works to treat solid tumors.

The study will have two parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Head and Neck Squamous Cell Cancer Breast Cancer Esophageal Cancer Ovarian Cancer Cutaneous Squamous Cell Cancer Exocrine Pancreatic Adenocarcinoma Bladder Cancer Cervical Cancer Gastric Cancer Drug: SGN-B6A Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 235 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023


Arm Intervention/treatment
Experimental: SGN-B6A Drug: SGN-B6A
Administered intravenously (IV; into the vein)




Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events (AEs) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  2. Number of participants with Grade 3 or higher AEs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  3. Number of participants with serious AEs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  4. Number of participants with treatment-related AEs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  5. Number of patients with laboratory abnormalities [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  6. Number of participants with DLTs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  7. Number of participants with a DLT at each dose level [ Time Frame: Up to 21 days ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve (AUC) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    Pharmacokinetic (PK) endpoint

  2. Concentration at the end of infusion (Ceoi) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    PK endpoint

  3. Maximum concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    PK endpoint

  4. Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    PK endpoint

  5. Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    PK endpoint

  6. Apparent terminal elimination half-life (t1/2) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    PK endpoint

  7. Number of participants with antidrug antibodies [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  8. Objective response rate (ORR) per RECIST v1.1 [ Time Frame: Up to approximately 3 years ]
    The proportion of participants with complete response (CR) or partial response (PR)

  9. Duration of objective response (DOR) [ Time Frame: Up to approximately 3 years ]
    The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause

  10. Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ]
    The time from first response to the first documentation of disease progression, or death due to any cause

  11. Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
    The time from start of study treatment to the date of death due to any cause



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:

  • Disease indication

    • Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part). Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic option.
  • Non-small cell lung cancer (NSCLC)
  • Head and neck squamous cell cancer (HNSCC)
  • Breast cancer
  • Esophageal cancer
  • Cutaneous squamous cell cancer (SCC)
  • Exocrine pancreatic adenocarcinoma
  • Bladder cancer
  • Cervical cancer
  • Gastric cancer
  • Ovarian cancer
  • Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:

    • Disease-specific expansion cohorts, participant 13 onwards: pre-treatment biopsy
    • Biology expansion cohort: pre-treatment biopsy and additional on-treatment biopsy during Cycle 1
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Measurable disease per the RECIST v1.1 at baseline

Exclusion Criteria

  • History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
  • Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:

    • are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
    • have no new or enlarging brain metastases, and
    • are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
  • Carcinomatous meningitis
  • Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6
  • Pre-existing neuropathy Grade 2 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
  • Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-B6A.

    • Routine antimicrobial prophylaxis is permitted
  • Positive for hepatitis B by surface antigen expression or active hepatitis C infection. Participants who have been treated for hepatitis C infection are permitted if they have documented sustained virolgic response of 12 weeks
  • Known to be positive for human immunodeficiency virus (HIV)
  • Documented history of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to their first dose of SGN-B6A
  • Congestive heart failure (Class III or IV) by New York Heart Association criteria
  • Grade 3 or higher pulmonary disease unrelated to underlying malignancy
  • Participant is expected to receive other anti-neoplastic or investigational agents prior to the end of treatment visit
  • During dose escalation only, use of strong CYP3A inhibitors within 14 days of study drug dosing
  • Chemotherapy, immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment.
  • Focal radiotherapy or surgery that is not completed 2 weeks prior to the first dose of SGN-B6A
  • Known hypersensitivity to any excipient contained in the drug formulation of SGN-B6A
  • Estimated life expectancy of <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): NCT04389632


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

Locations
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United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Stephanie Stamatis    216-844-7087    Stephanie.Stamatis@UHhospitals.org   
Principal Investigator: Afshin Dowlati         
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Lauryn Tuckett    210-593-5242    lauryn.tuckett@startsa.com   
Principal Investigator: Amita Patnaik         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Natalya Nazarenko, MD Seattle Genetics, Inc.
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT04389632    
Other Study ID Numbers: SGNB6A-001
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
NSCLC
HNSCC
cSCC
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type