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RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
A Phase I Study to Evaluate the Safety and Efficacy of RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer

Clinical Trial Summary

This is a Phase I, multi center study to evaluate the safety and efficacy and determine the maximum tolerated dose (MTD) of RP72 as monotherapy and RP72 in combination with Gemcitabine in patients with pancreatic cancer. The study has two arms: Arm A: RP72 monotherapy Arm B: RP72 in combination with Gemcitabine Both treatment arms will follow a standard 3+3 design. Up to 48 adult patients with pancreatic cancer will be enrolled in this study.

Clinical Trial Description

RP72 (Rise Prot-72) is a small molecular weight protein which directly binds to CXCR1 and CXCR2, which are the receptors of CXCL8 [Interleukin 8 (IL-8) or chemokine (C-X-C motif) ligand 8] and ELR-CXC chemokine. Therefore, RP72 can inhibit the binding of CXCL8 to its receptors CXCR1/2 and further block CXCL8-mediated signal transduction. Nonclinical studies have demonstrated that RP72 binds to the receptors of CXCL8 and blocks activation of CXCL8-mediated signaling transduction pathways, which decreases proliferation of susceptible tumor cells, especially the pancreatic cancer cells. In this Phase I study, RP-72 will be used as monotherapy or in combination with gemcitabine in adult patients with pancreatic cancer. The study aims to to evaluate the safety and efficacy, and to determine the MTD and recommended Phase II dose of RP72 monotherapy and RP72 in combination with Gemcitabine in patients with Pancreatic Cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04338763
Study type Interventional
Source Rise Biopharmaceuticals, Inc.
Contact Helen Wang, Master
Phone +886-2-2351-1190
Email Helen.Wang@ttopcro.com.tw
Status Recruiting
Phase Phase 1
Start date April 19, 2021
Completion date December 31, 2025
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