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

NCT02952989 | Terminated Phase 1 FDA Drug

• 1 other identifier: SGN2FF-001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Keywords

MSI-high; dMMR; PD-L1

Outcome Measures

Primary Outcomes (3)

• The number of participants with adverse events that are related to treatment

  The number of patients who have side effects that are related to the study drug

  Up to 90 days following last dose

• The number of participants with laboratory abnormalities that are related to treatment

  The number of patients who have laboratory test results that are outside the normal range

  Up to 90 days following last dose

• Incidence of dose-limiting toxicities (DLTs)

  The rate of occurrence of side effects that prevent giving more of the treatment

  28 days from first dose

Secondary Outcomes (8)

• Pharmacokinetic assessments

  Relative to most recent dosing event

• Markers of fucosylation status

  Up to 90 days following last dose

• Objective response rate

  Up to 90 days following last dose

• Disease control rate

  Up to approximately 5 years

• Duration of response

  Up to approximately 5 years

Study Arms (2)

SGN-2FF

EXPERIMENTAL

Dose escalation and dose expansion

Drug: SGN-2FF

SGN-2FF and Pembrolizumab

EXPERIMENTAL

Dose escalation and dose expansion

Drug: SGN-2FF; Drug: pembrolizumab

Interventions

SGN-2FF DRUG

SGN-2FF oral daily dosing.

Also known as: 2-fluorofucose

SGN-2FF; SGN-2FF and Pembrolizumab

pembrolizumab DRUG

200 mg every 3 weeks by IV infusion

Also known as: Keytruda

SGN-2FF and Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

University of Colorado Hospital / University of Colorado

Aurora, Colorado, 80045-0510, United States

Location

Winship Cancer Institute / Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4095, United States

Location

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Breast Neoplasms; Urinary Bladder Neoplasms; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Urinary Bladder Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Christina Derleth, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 2, 2016
• Study Start: February 23, 2017
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

US (11)