A Phase 1, Multicenter, Open-label, Dose-Escalation Study of SGN-2FF in Patients with Advanced Solid Tumors

This study will examine the safety profile of SGN-2FF given orally to patients with advanced solid tumors. Patients may continue treatment until progression of their disease or intolerable side effects. The primary goal of the study is to identify the optimal biological dose that does not exceed the maximum tolerated dose (MTD). The pharmacokinetics (PK) and antitumor activity of SGN-2FF will also be evaluated in the study.

Inclusion Criteria:
• Patients with histologically or cytologically-confirmed, locally advanced, or metastatic solid malignancy that is relapsed, refractory, or progressing following at least 1 prior systemic therapy
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
• Patients in Part B must have histologically or cytologically-confirmed non-small cell lung cancer that is documented Stage IIIB or IV, or recurrent disease following radiation therapy or surgical resection

Exclusion Criteria:
• Patients with carcinomatous meningitis or active central nervous system (CNS) metastases
• Patients with recent or serious ongoing infection
• Patients requiring systemic treatment with corticosteroids (greater than 10 prednisone equivalents) or immunosuppressive medications within 14 days of enrollment
• Patients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapy
• Known active or latent tuberculosis
• Uncontrolled diabetes mellitus
• History of interstitial lung disease
• Gastrointestinal abnormality that would affect absorption of SGN-2FF
Phase I
Multiple Tumor Types
Rachel Sanborn, M.D.
Seattle Genetics Inc.
Kim Sutcliffe
  • Oncology and Hematology Care Eastside