A Study of SGN-B6A in Advanced Solid Tumors

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