A Study of SGN-B6A in Advanced Solid Tumors

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

Tracking Information

• First Submitted Date: May 12, 2020
• First Posted Date: May 15, 2020
• Last Update Posted Date: February 2, 2021
• Actual Study Start Date: June 8, 2020
• Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: A Study of SGN-B6A in Advanced Solid Tumors
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• 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

Drug: SGN-B6A

Administered intravenously (IV; into the vein)

Study Arms

Experimental: SGN-B6A

Intervention: Drug: SGN-B6A

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 12, 2020): 235
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2023
• Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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
• 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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: France, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT04389632
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Seagen Inc.
• Study Sponsor: Seagen Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Natalya Nazarenko, MD; Seagen Inc.

• PRS Account: Seagen Inc.
• Verification Date: January 2021