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

Status: administratively complete

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.

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

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.

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

Inclusion Criteria

Exclusion Criteria

United States

North Carolina

Durham

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

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