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



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:February 23, 2017
End Date:August 2022
Contact:Seattle Genetics Trial Information Support
Email:clinicaltrials@seagen.com
Phone:866-333-7436

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

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.

This is a phase 1, open-label, multicenter, dose escalation study that will examine the
safety profile of SGN-2FF given orally to patients with advanced solid tumors. The primary
goal of the study is to identify the maximum tolerated dose (MTD), or optimal biological dose
(OBD) that does not exceed the MTD. The pharmacokinetics (PK) and antitumor activity of
SGN-2FF will also be evaluated. In this study, SGN-2FF will be evaluated as monotherapy and
as combination therapy with the standard approved dose of pembrolizumab.

The monotherapy portion of the study will be conducted in 2 sequential parts (Part A and Part
B). Part A will enroll patients for dose escalation to estimate the MTD /OBD and help
determine the dosing regimen that will be tested in Part B. The OBD will be evaluated by
assessing the activity of SGN-2FF, including pharmacodynamics, PK, and other observations in
dose escalation. Part B will explore the recommended dose/regimen in up to 3 focused
expansion cohorts.

The combination therapy portion of the study will be conducted in 2 sequential parts (Part C
and Part D). SGN-2FF will be administered orally according to the dose and schedule assigned,
with a lead-in period of 2 weeks prior to pembrolizumab administration. The lead-in period
may be discontinued based on emerging nonclinical and/or clinical data. Part C will enroll
patients for dose escalation to estimate the MTD /OBD and the dosing regimen that will be
tested in Part D. Part D will explore the recommended dose/regimen in up to 3 focused
expansion cohorts.

Safety will be monitored throughout the trial by the safety monitoring committee which will
meet frequently to review the emerging safety data and make dose-escalation and
dosing-interval recommendations. Antitumor activity will be assessed by radiographic imaging.
Patients may continue treatment until progression of their disease or intolerable side
effects.

Retreatment with SGN-2FF monotherapy or with SGN-2FF and pembrolizumab combination therapy is
permitted with medical monitor approval for patients who achieve stable disease, a complete
response, or partial response on study and then experience disease progression after
discontinuing prior treatment with SGN 2FF.

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
We found this trial at
11
sites
Houston, Texas 77030
Principal Investigator: Timothy Yap, MD
Phone: 713-563-1784
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Francisco Robert, MD
Phone: 205-996-0988
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Rachel Sanborn, MD
Phone: 503-215-5763
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Atlanta, Georgia 30322
Principal Investigator: Conor Steuer, MD
Phone: 404-778-5378
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Aurora, Colorado 80045
Principal Investigator: Ross Camidge, MD PhD
Phone: 720-848-0300
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Khanh Do, MD
Phone: 617-582-7835
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Detroit, Michigan
Principal Investigator: Amy Weise, MD
Phone: 313-576-8624
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Karen Reckamp, MD
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: John Strickler, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Howard Burris, MD
Phone: 877-691-7274
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Seattle, Washington 98109
Principal Investigator: Laura Chow, MD
Phone: 206-288-6538
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Seattle, WA
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