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Trial record 1 of 1 for:    SGNB6A-001
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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 : November 28, 2022
Sponsor:
Information provided by (Responsible Party):
Seagen 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
Carcinoma, Non-Small Cell Lung Squamous Cell Carcinoma of Head and Neck HER2 Negative Breast Neoplasms Esophageal Squamous Cell Carcinoma Esophageal Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Ovarian Neoplasms Cutaneous Squamous Cell Cancer Exocrine Pancreatic Adenocarcinoma Urinary Bladder Neoplasms Uterine Cervical Neoplasms Stomach Neoplasms Drug: SGN-B6A Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 355 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 : July 31, 2024
Estimated Study Completion Date : October 31, 2024


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




Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
    Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  2. Number of patients with laboratory abnormalities [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]
  3. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Through 30-37 days following last dose of SGN-B6A; up to 3 years ]

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

  4. Time to maximum observed 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 (ADAs) [ 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 the start of any study treatment 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 the start of any study treatment to the date of death due to any cause



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:

  • 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)
  • Advanced HER2-negative breast cancer
  • Esophageal squamous cell carcinoma (ESCC)
  • Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)
  • Cutaneous squamous cell cancer (cSCC)
  • Exocrine pancreatic adenocarcinoma
  • Bladder cancer
  • Cervical cancer
  • Gastric cancer
  • High grade serous ovarian cancer (HGSOC)
  • 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 16 onwards: pretreatment biopsy
    • Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy
  • 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

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: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, Florida
Florida Cancer Specialists - Lake Nona Recruiting
Orlando, Florida, United States, 32827
Contact: Ingrid Acker    689-216-8500    Ingrid.Acker@SarahCannon.com   
Principal Investigator: Cesar Perez Batista, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Taylor Burns       tburns4@bidmc.harvard.edu   
Principal Investigator: Bruno Bockorny         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mary Liebers       MaryK_Liebers@DFCI.HARVARD.EDU   
Contact: Illya Dixon       Illya_Dixon@dfci.harvard.edu   
Principal Investigator: Kartik Sehgal         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Edwin Kingsley       edwin.kingsley@usoncology.com   
Principal Investigator: Edwin Kingsley         
United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Megan Magdinec       Megan.Magdinec@UHhospitals.org   
Principal Investigator: Afshin Dowlati         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Providence Cancer Institute       CanClinRsrchStudies@providence.org   
Principal Investigator: Rachel Sanborn         
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Rabia Khan       RKhan@mdanderson.org   
Principal Investigator: Sarina Piha-Paul         
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez       isabel.jimenez@startsa.com   
Principal Investigator: Amita Patnaik         
France
Institut Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Principal Investigator: Antoine Hollebecque         
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: Elena Garralda Cabanas         
Hospital Universitario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Principal Investigator: Emiliano Calvo         
Switzerland
University Hospital Lausanne CHUV Recruiting
Lausanne, Switzerland, 1011
Principal Investigator: Solange Peters         
United Kingdom
The Royal Marsden Hospital (Surrey) Recruiting
Sutton, United Kingdom, SM2 5PT
Principal Investigator: Juanita Lopez         
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Natalya Nazarenko, MD Seagen Inc.
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04389632    
Other Study ID Numbers: SGNB6A-001
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: November 2022
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 Seagen Inc.:
NSCLC
HNSCC
cSCC
ESCC
EAC
GEJ
HGSOC
Advanced HER2-Negative Breast Cancer
High Grade Serous Ovarian Cancer
Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Cancer
Esophageal Cancer
Bladder Cancer
Cervical Cancer
Gastric Cancer
Seattle Genetics
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Breast Neoplasms
Esophageal Squamous Cell Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Squamous Cell
Ovarian Neoplasms
Stomach Neoplasms
Squamous Cell Carcinoma of Head and Neck
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms