SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Study of SGN-2FF in Patients With Advanced Solid Tumors

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


  • Org Study ID: SGN2FF-001
  • Secondary ID:
  • NCT ID: NCT02952989
  • NCT Alias:
  • Sponsor: Seattle Genetics, Inc. - Industry
  • Source: Seattle Genetics, Inc.

Brief 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.

Detailed Description


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.

Overal Status Start Date Phase Study Type
Recruiting February 23, 2017 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: The number of participants with adverse events that are related to treatment

Primary Outcome 1 - Time Frame: Up to 90 days following last dose

Primary Outcome 2 - Measure: The number of participants with laboratory abnormalities that are related to treatment

Primary Outcome 2 - Time Frame: Up to 90 days following last dose

Primary Outcome 3 - Measure: Incidence of dose-limiting toxicities (DLTs)

Primary Outcome 3 - Time Frame: 28 days from first dose

Condition:

  • 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

Eligibility

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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Christina Derleth, MD

Role: Study Director

Affiliation: Seattle Genetics, Inc.

Overall Contact

Name: Seattle Genetics Trial Information Support

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

Locations

Facility Status Contact
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Recruiting Jennifer Garcia, MD
205-996-0988
jennifergarcia@uabmc.edu
City of Hope National Medical Center
Duarte, California 91010-3000
United States
Recruiting Karen Reckamp, MD
626-256-4673
kreckamp@coh.org
University of Colorado Hospital / University of Colorado
Aurora, Colorado 80045-0510
United States
Recruiting Ross Camidge
720-848-0300
ross.camidge@ucdenver.edu
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia 30322
United States
Recruiting Conor Steuer, MD
404-778-5378
Csteuer@emory.edu
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting Sarah Desmarais
617-582-7835
Sarah_Desmarais@DFCI.HARVARD.EDU
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan 48201
United States
Recruiting Amy Weise
313-576-8624
weisea@karmanos.org
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Recruiting Sora Limor
551-996-8598
SLimor@hackensackumc.org
Duke University Medical Center
Durham, North Carolina 27710
United States
Recruiting John Strickler
919-684-8111
john.strickler@dm.duke.edu
Providence Portland Medical Center
Portland, Oregon 97213
United States
Recruiting Kim Sutcliffe
503-215-5763
kimberly.sutcliffe@providence.org
Sarah Cannon Research Institute
Nashville, Tennessee 30384
United States
Recruiting Ask Sarah
877-691-7274
ASKSARAH@scresearch.net
MD Anderson Cancer Center / University of Texas
Houston, Texas 77030-4095
United States
Recruiting Timothy Yap, MBBS
713-563-1784
tyap@mdanderson.org
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington 98109-1023
United States
Recruiting Erica Peters
206-288-6538
etucker@u.washington.edu