Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-064
Prinicipal Investigator
Drabick, Joseph
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
RPL-001-16
Title
An Open-Label, Multicenter, Phase I/II Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
Objective
Phase I: To determine the maximum tolerated dose (MTD) as determined by incidence of dose limiting toxicities (DLT) and/or the RP2D of RP1.
To assess the safety and tolerability of RP1 alone and in combination with nivolumab as determined by the incidence of all treatment-emergent adverse events (TEAEs), ≥ Grade 3 TEAEs, serious adverse events (SAEs), and TEAEs requiring withdrawal from investigational product (IP) treatment.
Phase II: To assess the safety and tolerability of RP1 in combination with nivolumab as determined by the incidence of all TEAEs, ≥ Grade 3 TEAEs, SAEs, and TEAEs requiring withdrawal from IP treatment
To assess the efficacy of RP1 in combination with nivolumab as determined by ORR using RECIST 1.1 criteria
Applicable Disease Sites
Melanoma, Skin

Other Gastrointestinal
Status
Open
Participating Institutions
Hershey Medical Center