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

Status: Terminated
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
City of Hope National Medical Center
Duarte
Colorado
University of Colorado Hospital / University of Colorado
Aurora
Georgia
Winship Cancer Institute / Emory University School of Medicine
Atlanta
Massachusetts
Dana Farber Cancer Institute
Boston
Michigan
Karmanos Cancer Institute / Wayne State University
Detroit
North Carolina
Duke University Medical Center
Durham
Oregon
Providence Portland Medical Center
Portland
Tennessee
Sarah Cannon Research Institute
Nashville
Texas
MD Anderson Cancer Center / University of Texas
Houston
Washington
Seattle Cancer Care Alliance / University of Washington
Seattle
Time Frame
Start Date: 2017-02-23
Completion Date: 2019-06-24
Participants
Target number of participants: 47
Treatments
Experimental: SGN-2FF
Dose escalation and dose expansion
Experimental: SGN-2FF and Pembrolizumab
Dose escalation and dose expansion
Sponsors
Leads: Seagen Inc.

This content was sourced from clinicaltrials.gov

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