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

Stopped early · Phase 1

Conditions studied: Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Breast Neoplasms, Urinary Bladder Neoplasm, Carcinoma, Squamous Cell of Head and Neck, Colorectal Neoplasms, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT02952989

Run by

Seagen Inc.

People needed

47

Starts

2017-02-23

Expected to finish

2019-06-24

Last updated by the study team

2019-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of Colorado Hospital / University of Colorado — Aurora, Colorado, United States
• Winship Cancer Institute / Emory University School of Medicine — Atlanta, Georgia, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute / Wayne State University — Detroit, Michigan, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center / University of Texas — Houston, Texas, United States
• Seattle Cancer Care Alliance / University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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