TheranosticTrials.org

Clinical Trial · NCT00293215

Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen

Overview

This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium \[111-In\]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.

Sponsor

Olivia Newton-John Cancer Research Institute

Phase

Phase 1

Contacts

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

ClinicalTrials.gov

NCT00293215

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

CMD-193

Isotope(s):
Target(s):
  • Lewis Y antigen
Ligand Class: Antibodies
Chelator: CHX-A''-diethylenetriaminepentaacetic acid

Eligibility

Inclusion

  • Any other condition that, in the Investigator's judgment, would have substantially increased the risk associated with the subject's participation in this study.
  • Tumor expression of Lewis-Y antigen (≥20% tumor cells positive for Lewis-Y by immunohistochemistry assay).
  • Symptomatic or clinically active central nervous system (CNS) metastases. Subjects who had prior treatment with radiotherapy or surgical resection for CNS metastases were permitted if CNS metastases had remained stable and not required any treatment for at least 3 months prior to the first dose of CMD-193.
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST), including the presence of at least one measurable lesion at least 2 cm in size suitable for 18F-FDG PET imaging.
  • Pancreatic tests: amylase ≤1.5 x ULN and lipase ≤ 1.5 x ULN.
  • Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C).
  • Unstable or serious concurrent medical conditions. Examples included, but were not limited to, bleeding gastric ulcers, gastrointestinal bleeding, hepatitis, significant disorders of the immune system (eg, systemic lupus erythematosus), pancreatitis, congestive heart failure, serious active infections (e.g. requiring antibiotics or antiviral agents), unstable angina, recent myocardial infarction (within 6 months of screening), ongoing maintenance therapy for life-threatening ventricular arrhythmia, or uncontrolled major seizure disorder.
  • Histologically confirmed malignant solid tumor that had progressed following standard therapy, or for which no standard effective treatment was available.

Exclusion

Exclusion criteria not yet provided.