Clinical Trials /

A Study of SGN-B6A in Advanced Solid Tumors

NCT04389632

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Breast Carcinoma
  • Cervical Carcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Adenocarcinoma
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of SGN-B6A in Advanced Solid Tumors
  • Official Title: A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: SGNB6A-001
  • NCT ID: NCT04389632

Conditions

  • 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

Interventions

DrugSynonymsArms
SGN-B6ASGN-B6A

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
SGN-B6AExperimental
  • SGN-B6A

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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Area under the concentration-time curve (AUC)
Time Frame:Through 30-37 days following last dose of SGN-B6A; up to 3 years
Safety Issue:
Description:Pharmacokinetic (PK) endpoint
Measure:Concentration at the end of infusion (Ceoi)
Time Frame:Through 30-37 days following last dose of SGN-B6A; up to 3 years
Safety Issue:
Description:PK endpoint
Measure:Maximum concentration (Cmax)
Time Frame:Through 30-37 days following last dose of SGN-B6A; up to 3 years
Safety Issue:
Description:PK endpoint
Measure:Time to maximum concentration (Tmax)
Time Frame:Through 30-37 days following last dose of SGN-B6A; up to 3 years
Safety Issue:
Description:PK endpoint
Measure:Trough concentration (Ctrough)
Time Frame:Through 30-37 days following last dose of SGN-B6A; up to 3 years
Safety Issue:
Description:PK endpoint
Measure:Apparent terminal elimination half-life (t1/2)
Time Frame:Through 30-37 days following last dose of SGN-B6A; up to 3 years
Safety Issue:
Description:PK endpoint
Measure:Number of participants with antidrug antibodies
Time Frame:Through 30-37 days following last dose of SGN-B6A; up to 3 years
Safety Issue:
Description:
Measure:Objective response rate (ORR) per RECIST v1.1
Time Frame:Up to approximately 3 years
Safety Issue:
Description:The proportion of participants with complete response (CR) or partial response (PR)
Measure:Duration of objective response (DOR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description: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
Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:The time from first response to the first documentation of disease progression, or death due to any cause
Measure:Overall survival (OS)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:The time from start of study treatment to the date of death due to any cause

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Genetics, Inc.

Trial Keywords

  • NSCLC
  • HNSCC
  • cSCC

Last Updated

June 9, 2020