TheranosticTrials.org

Clinical Trial · NCT00291447

111In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen

Overview

The purpose of this clinical trial is to describe the toxicity, biodistribution, pharmacokinetics and tumour uptake of a single infusion of ch806 (tagged with a trace amount of radioactive 111-Indium: 111In-ch806) in patients with advanced tumours expressing the 806 antigen.

Sponsor

Olivia Newton-John Cancer Research Institute

Phase

Phase 1

Contacts

A/Prof Andrew M Scott, MBBS MD DDU (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00291447

Drug / Compound

ch806

Isotope(s):
Target(s):
  • EGFR
Ligand Class: Antibodies
Chelator: CHX-A''-DTPA

Eligibility

Inclusion

  • Within the last 2 weeks vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: Neutrophil count \>/= 1.5 x 10\^9/L; Platelet count \>/= 150 x 10\^9/L; Serum bilirubin \< 34 micromol/L; Creatinine clearance \> 50ml/min
  • Histologically or cytologically proven malignancy.
  • Measurable disease on CT scan with at least one lesion \>/= 2 cm diameter (to allow adequate imaging).
  • Patients with advanced or metastatic tumours which are positive for 806 antigen expression based on chromogenic in situ hybridization (CISH) or immuno-histochemistry (IHC) of archived tumour samples.
  • Karnofsky performance scale \>/= 70.

Exclusion

  • Lack of availability for immunological and clinical follow-up assessments.
  • Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
  • Prior administration of monoclonal antibody or antibody fragment, and positive human anti-chimeric antibody (HACA) titre.
  • Untreated active metastatic disease to the central nervous system (new or enlarging lesions on CT or MRI), or within 3 months of treatment (i.e. surgery or radiotherapy) for brain metastases. Primary central nervous system tumour (e.g. Glioblastoma Multiforme) is not an exclusion criterion.