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131Iodine-Tenatumomab Treatment in Tenascin-C Positive Cancer Patients

NCT02602067 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-09-18

No results posted yet for this study

Summary

Tenatumomab is a Sigma-Tau developed new anti-Tenascin antibody. It is a murine monoclonal antibody directed towards Tenascin-C. By means of this antibody, Tenascin-C expression was studied on a commercial tissue array slides each carrying malignant breast, colorectal, lung, ovarian or B and T cell Non-Hodgkin Limphoma tissue sections. All these cancers type showed positivity to Tenascin-C between the 64% and 13.3%. Consequently, Sigma-tau is exploring the use of the 131I-labeled Tenatumomab for anti-cancer radioimmunotherapy.

Conditions

  • Breast Neoplasm
  • Head and Neck Neoplasm
  • Skin Neoplasm
  • Respiratory Tract Neoplasm
  • Urogenital Neoplasm
  • Digestive System Neoplasm
  • Pancreatic Neoplasm
  • Connective and Soft Tissue Neoplasm
  • Lymphoma, Non-Hodgkin

Interventions

COMBINATION_PRODUCT

131I-Tenatumomab

I131anti-Tenascin monoclonal antibody administered to be targeted on neoplasms expressing Tenascin-C

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • sigma-tau i.f.r. S.p.A.

    lead INDUSTRY

Principal Investigators

  • SECONDO LASTORIA, M.D. · ISTITUTO NAZIONALE DEI TUMORI IRCCS - FONDAZIONE "G. PASCALE" NAPLES - ITALY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02602067 on ClinicalTrials.gov