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A Study of SGN-B6A in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04389632
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Tracking Information
First Submitted Date  ICMJE May 12, 2020
First Posted Date  ICMJE May 15, 2020
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE June 8, 2020
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2020)
  • 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 ]
  • 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 ]
  • Number of participants with serious AEs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  • Number of participants with treatment-related AEs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  • Number of patients with laboratory abnormalities [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  • Number of participants with DLTs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  • Number of participants with a DLT at each dose level [ Time Frame: Up to 21 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Number of participants with treatment-emergent adverse events (AEs) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
  • Number of participants with Grade 3 or higher AEs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
  • Number of participants with serious AEs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
  • Number of participants with treatment-related AEs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
  • Number of patients with laboratory abnormalities [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
  • Number of participants with DLTs [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
  • Number of participants with a DLT at each dose level [ Time Frame: Up to 21 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2020)
  • 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
  • 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
  • Maximum concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    PK endpoint
  • Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    PK endpoint
  • Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    PK endpoint
  • 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
  • Number of participants with antidrug antibodies [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  • 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)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Area under the concentration-time curve (AUC) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
    Pharmacokinetic (PK) endpoint
  • Concentration at the end of infusion (Ceoi) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
    PK endpoint
  • Maximum concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
    PK endpoint
  • Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
    PK endpoint
  • Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
    PK endpoint
  • Apparent terminal elimination half-life (t1/2) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
    PK endpoint
  • Number of participants with antidrug antibodies [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 2 years ]
  • 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)
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SGN-B6A in Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
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.

Detailed Description Not Provided
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
  • 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
Intervention  ICMJE Drug: SGN-B6A
Administered intravenously (IV; into the vein)
Study Arms  ICMJE Experimental: SGN-B6A
Intervention: Drug: SGN-B6A
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
235
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2023
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Uncontrolled diabetes mellitus
  • 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
  • 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
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: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE France,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04389632
Other Study ID Numbers  ICMJE SGNB6A-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
Plan to Share IPD: No
Responsible Party Seagen Inc.
Study Sponsor  ICMJE Seagen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Natalya Nazarenko, MD Seagen Inc.
PRS Account Seagen Inc.
Verification Date January 2021

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