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

Lymphoma, Non-Hodgkin Clinical Trial

Official title: A Dose Escalation Study to Evaluate Safety, Tolerability Dosimetry, Pharmacokinetics and Preliminary Efficacy of 131I-Tenatumomab Treatment in Tenascin-C Positive Cancer Patients

Status Terminated

Clinical Trial 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.

Clinical Trial Description

This will be an open-label dose escalation study. The study will be conducted in two steps:

1. STEP A aims to identify the optimal amount of antibody to convey the specific radio-label activity of radionuclide.

2. STEP B will be conducted with the amount of antibody chosen in STEP A, and an escalating radio-labeled therapeutic dose response curve will be performed (3.5 to 5.5 GBq) A maximum of 36 evaluable patients suffering from treatment-refractory Tenascin-C positive tumors.

This dose escalation study will be evaluated using descriptive statistics: no sample size calculation was performed

Primary objectives

1. To identify the Maximum Tolerated Dose (MTD) and assess Safety and Tolerability of i.v. infused 131I-Tenatumomab.

2. To identify the optimal amount of unlabeled Tenatumomab able to convey 131I- Tenatumomab with the highest Tumor/nonTumor ratio.

3. To evaluate the whole body Dosimetry (safety dosimetry) and Tumor to normal tissue ratio (T/nT ratio, referred to AUC) of i.v.infused 131I-Tenatumomab.

4. To evaluate intra-lesional distribution and retention of 131I-Tenatumomab and to record individual lesion dosimetry.

5. To evaluate systemic biodistribution, pharmacokinetics, urinary excretion and dose linearity of 131I-Tenatumomab.

Secondary objectives

1. To evaluate proportional 131I-Tenatumomab tumor binding, as a function of the total load.

2. To evaluate Pharmacokinetics of Tenatumomab (protein and protein related materials) in serum.

3. To evaluate preliminary Efficacy of 131I-Tenatumomab based on disease response rate (Complete Response, Partial Response, Stable Disease) and patient's general clinical condition by ECOG performance status assessment. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02602067
• Study type: Interventional
• Source: sigma-tau i.f.r. S.p.A.
• Status: Terminated
• Phase: Phase 1
• Start date: November 2015
• Completion date: April 30, 2017