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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSGN-2FF and pembrolizumab

The study team can explain what participation involves.

Who it may be forCarcinoma, Non-Small-Cell Lung · Carcinoma, Renal Cell

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 19, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?11 U.S. locations

Locations may change over time.

Who runs it?Seagen Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Seagen Inc.
Interventions being studied: Drug: SGN-2FF; Drug: pembrolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Alabama at BirminghamBirmingham, Alabama
City of Hope National Medical CenterDuarte, California
University of Colorado Hospital / University of ColoradoAurora, Colorado
Winship Cancer Institute / Emory University School of MedicineAtlanta, Georgia
Dana Farber Cancer InstituteBoston, Massachusetts
Karmanos Cancer Institute / Wayne State UniversityDetroit, Michigan
Duke University Medical CenterDurham, North Carolina
Providence Portland Medical CenterPortland, Oregon
Sarah Cannon Research InstituteNashville, Tennessee
MD Anderson Cancer Center / University of TexasHouston, Texas
Seattle Cancer Care Alliance / University of WashingtonSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 19, 2019. Always confirm current availability with the study team.

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