Trial intelligence / Profile preview

NPC-1C in advanced pancreatic and colorectal cancer

NCT01040000Phase 2

Key facts

Status: Completed
Start: Jan 2012
Primary completion: Mar 2017
Countries: 1
Sponsor: Precision Biologics
Modality: Monoclonal Antibodies

Drugs: ensituximab
Conditions: pancreatic cancer (PC)colorectal cancer (CRC)

Overview

Phase 2, open-label, single-arm trial of ensituximab in pancreatic cancer (PC) and colorectal cancer (CRC), sponsored by Precision Biologics. Primary endpoints: Objective Response Rate at 10 weeks and Overall Survival at 5 months. Started Jan 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

NPC-1C/NEO-102
Ensituximab 3.0 mg/kg IV every 2 weeks

Who it enrols

Adults with recurrent/metastatic pancreatic or colorectal adenocarcinoma who have progressed on standard therapy, with tumors staining >= 20% positive for NPC-1C antigen.

Endpoints

Primary

Objective Response Rate10 weeks
Overall Survival5 months

Secondary

Safety and Tolerability10 weeks
Pharmacokinetics10 weeks
Anti-Drug Antibodies10 weeks

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