A Safety Study of SGN-2FF for Patients With Advanced Solid Tumors

• Status: Terminated
• Trial end date: 2019-06-24
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to find out the side effects (unwanted effects) that are caused in patients with cancers who are given SGN-2FF. This study will also attempt to find the most suitable dose in the disease or condition being studied and look at other effects of SGN2FF, including its effect on cancer.

This study has several different parts. Part A will try to find the highest safe dose. Part B will enroll more patients to be treated at the highest safe dose or a lower dose to better understand how well SGN-2FF is tolerated. Part C will try to find the highest safe dose of SGN-2FF when it is given combined with pembrolizumab. Pembrolizumab is a standard treatment for cancer. Part D will enroll more patients to be treated at the highest safe dose of SGN-2FF combined with pembrolizumab or a lower dose of SGN-2FF to better understand how well SGN-2FF is tolerated when it is given with pembrolizumab.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Pembrolizumab

Criteria

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 (Part A)

• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1

• Patients in Part B must have histologically or cytologically-confirmed, locally-advanced, or metastatic solid malignancy within the disease indications of Part A

• Adequate baseline hematologic, renal, and hepatic function

• Patients for whom there is no further standard therapy available at the time of enrollment (Part A)

• Patients with a histologically-confirmed, advanced solid malignancy meeting one of the following criteria: (1) indication for which pembrolizumab is approved or (2) relapsed, refractory, or progressive disease following at least 1 prior therapy and for which no further standard therapy is a available (Parts C and D)

Exclusion Criteria:

• Patients with carcinomatous meningitis or active central nervous system (CNS) metastases

• Patients with recent (within 14 days) or serious ongoing infection

• Patients requiring systemic treatment with corticosteroids (greater than 10 mg 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

• Patients tested positive for hepatitis B or with a known, active hepatitis C infection

• Women who are pregnant or breastfeeding

• Patients with deep vein thrombosis (DVT)

• Contraindication to prophylactic anticoagulation