Trial intelligence / Profile preview

MicOryx: FSP Vaccination in MSI-H Colorectal Cancer

NCT01461148Phase 2

Key facts

Status
Completed
Start
Aug 2011
Primary completion
Mar 2015
Countries
1
Modality
Peptides, Vaccines & Immunotherapeutics
Drugs
HT001
Conditions
colorectal cancer (CRC)
01

Overview

Phase 2, open-label, single-arm trial of HT001 in colorectal cancer (CRC). Primary endpoint: Immune response against FSP peptides. Started Aug 2011; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • FSP peptides

    Vaccination with AIM2(-1), HT001(-1), and TAF1B(-1) combined with Montanide ISA-51 VG

03

Who it enrols

Patients with advanced MSI-H colorectal cancer (UICC stage III/IV) who have received or refused standard therapy, with ECOG 0-2 and adequate organ function.

04

Endpoints

Primary

  • Immune response against FSP peptides

Secondary

  • Tumor response

  • Safety

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