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

Breast Neoplasms Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Colorectal Neoplasms
• Esophageal Neoplasms
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Urinary Bladder Neoplasm
• Urinary Bladder Neoplasms

• NCT number: NCT02952989
• Study type: Interventional
• Source: Seattle Genetics, Inc.
• Status: Terminated
• Phase: Phase 1
• Start date: February 23, 2017
• Completion date: June 24, 2019