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Point Biopharma

Clinical Trial · NCT00399113

Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma

Overview

The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.

Sponsor

Point Biopharma

Phase

Phase 1

Contacts

Jacob Schachter, M.D. (PRINCIPAL_INVESTIGATOR)

Tzila Zwas, M.D. (PRINCIPAL_INVESTIGATOR)

Eithan Galun, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00399113

Eligibility

Inclusion

  • females of child-bearing potential must be practicing an acceptable method of birth control and have a negative urine pregnancy test;
  • Karnofsky status at least 50%;
  • measurable disease;
  • adequate organ and marrow function defined by screening laboratory tests;
  • at least 4 weeks since prior therapy;
  • life expectancy \> 3 months;
  • Histologically confirmed Stage IIIc (unresectable) or Stage IV metastatic melanoma;
  • negative screening human anti-murine antibodies;

Exclusion

  • uncontrolled intercurrent illness;
  • positive hep B surface Ag, hep C antibody, or HIV test at screening;
  • ocular inflammatory disease or ocular neoplasm (all patients must have fundoscopic and slit lamp examination within 2 weeks of treatment to rule out exclusionary ocular pathology);
  • brain metastasis (all patients must have contrast-enhanced MRI within 2 weeks of treatment to rule out);
  • pregnant/breast-feeding.
  • Chemotherapy or radiation therapy within 4 weeks or poor recovery from therapy \> 4 weeks ago;
  • prior parenteral exposure to murine proteins;
  • investigational drug within 30 days;

Patient Education

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