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

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ClinicalTrials.gov Identifier: NCT02952989
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
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 Drug: SGN-2FF Drug: pembrolizumab Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGN-2FF in Patients With Advanced Solid Tumors
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SGN-2FF
Dose escalation and dose expansion
Drug: SGN-2FF
SGN-2FF oral daily dosing.
Other Name: 2-fluorofucose

Experimental: SGN-2FF and Pembrolizumab
Dose escalation and dose expansion
Drug: SGN-2FF
SGN-2FF oral daily dosing.
Other Name: 2-fluorofucose

Drug: pembrolizumab
200 mg every 3 weeks by IV infusion
Other Name: Keytruda




Primary Outcome Measures :
  1. The number of participants with adverse events that are related to treatment [ Time Frame: Up to 90 days following last dose ]
    The number of patients who have side effects that are related to the study drug

  2. The number of participants with laboratory abnormalities that are related to treatment [ Time Frame: Up to 90 days following last dose ]
    The number of patients who have laboratory test results that are outside the normal range

  3. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 days from first dose ]
    The rate of occurrence of side effects that prevent giving more of the treatment


Secondary Outcome Measures :
  1. Pharmacokinetic assessments [ Time Frame: Relative to most recent dosing event ]
    Selected PK parameters, including area under the curve, maximum observed concentration, time to maximum observed concentration, and trough concentration.

  2. Markers of fucosylation status [ Time Frame: Up to 90 days following last dose ]
    Changes in pharmacodynamic biomarkers of fucosylation across dose levels

  3. Objective response rate [ Time Frame: Up to 90 days following last dose ]
    The proportion of patients who achieve a complete response (CR) or partial response (PR).

  4. Disease control rate [ Time Frame: Up to approximately 5 years ]
    The proportion of patients who achieve either complete response (CR), partial response (PR), or stable disease (SD)

  5. Duration of response [ Time Frame: Up to approximately 5 years ]
    The time from the first documentation of objective response (CR or PR) to the first documentation of tumor progression (progressive disease per response criteria or clinical disease progression) or to death due to any cause, whichever comes first

  6. Clinical benefit rate [ Time Frame: Up to approximately 5 years ]
    The proportion of patients who achieve either complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks

  7. Progression-free survival [ Time Frame: Up to approximately 5 years ]
    The time from start of study treatment to the first documentation of tumor progression (progressive disease per response criteria or clinical disease progression) or death due to any cause, whichever comes first

  8. Overall survival [ Time Frame: Up to approximately 5 years ]
    The time from start of study treatment to date of death due to any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952989


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jennifer Garcia, MD    205-996-0988    jennifergarcia@uabmc.edu   
Contact: Francisco Robert    205-934-5077    pacorobertuab@cs.com   
Principal Investigator: Francisco Robert, MD         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Karen Reckamp, MD    626-256-4673    kreckamp@coh.org   
Contact: Barbora Stankova    626-218-1138    bstankova@coh.org   
Principal Investigator: Karen Reckamp, MD         
United States, Colorado
University of Colorado Hospital / University of Colorado Recruiting
Aurora, Colorado, United States, 80045-0510
Contact: Ross Camidge    720-848-0300    ross.camidge@ucdenver.edu   
Principal Investigator: Ross Camidge, MD PhD         
United States, Georgia
Winship Cancer Institute / Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Conor Steuer, MD    404-778-5378    Csteuer@emory.edu   
Contact: Chavon Porter    404-778-7664    chavon.porter@emoryhealthcare.org   
Principal Investigator: Conor Steuer, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sarah Desmarais    617-582-7835    Sarah_Desmarais@DFCI.HARVARD.EDU   
Contact: Khanh Do    617-632-6992    khanh_do@dfci.harvard.edu   
Principal Investigator: Khanh Do, MD         
United States, Michigan
Karmanos Cancer Institute / Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Amy Weise    313-576-8624    weisea@karmanos.org   
Principal Investigator: Amy Weise, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Sora Limor    551-996-8598    SLimor@hackensackumc.org   
Principal Investigator: Martin Gutierrez, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: John Strickler    919-684-8111    john.strickler@dm.duke.edu   
Contact: Shawna Savage    919-668-1462    shawna.savage@duke.edu   
Principal Investigator: John Strickler, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Kim Sutcliffe    503-215-5763    kimberly.sutcliffe@providence.org   
Principal Investigator: Rachel Sanborn, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 30384
Contact: Ask Sarah    877-691-7274    ASKSARAH@scresearch.net   
Principal Investigator: Howard Burris, MD         
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4095
Contact: Timothy Yap, MBBS    713-563-1784    tyap@mdanderson.org   
Principal Investigator: Timothy Yap, MD         
United States, Washington
Seattle Cancer Care Alliance / University of Washington Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Erica Peters    206-288-6538    etucker@u.washington.edu   
Principal Investigator: Laura Chow, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Christina Derleth, MD Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02952989     History of Changes
Other Study ID Numbers: SGN2FF-001
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 31, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seattle Genetics, Inc.:
MSI-high
dMMR
PD-L1

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Adenocarcinoma
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Esophageal Neoplasms
Carcinoma, Renal Cell
Carcinoma, Squamous Cell
Urinary Bladder Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases