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Phase I, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies, Including Pancreatic Cancer

Summary

The purpose of this phase I study is to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

General Information

NCT#: NCT02376699
Study ID: SGNS40-001
Trial Phase: Phase I

Trial Sponsor: Seattle Genetics, Inc., Merck Sharp & Dohme Corp.
Therapies Used in This Trial: Nab-paclitaxel, Gemcitabine, Pembrolizumab, SEA-CD40

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