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Iodine

Cadexomer iodine

Diagnostic: each patient will receive one single i.v. infusion of 370 MBq±10% 131I-Tenatumomab in 10 ml of saline (conveyed by 10 ±10%, 20 ±10%, 40 ±10% mg of Tenatumomab). It will be administered as a short infusion in approximately 30 minutes (333 ° µl / min).

Therapeutic: each patient will receive one single i.v. infusion, escalating 131I-Tenatumomab dose starting at 2.5 GBq±10%,with escalation steps of 1 GBq, up to 5.5 GBq±10% in 10 ml of saline, (conveyed by 10 ±10% , 20 ±10%, 40 ±10% mg of Tenatumomab). It will be administered as a short infusion in approximately 30 minutes (333° µl / min)

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

131I-Tenatumomab

SECONDO LASTORIA, M.D.

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.

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.

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

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

Tumor response according to Response Evaluation Criteria in Solid Tumors RECIST V 1.1 or PERCIST

Medpace, Inc.

sigma-tau i.f.r. S.p.A.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
131Iodine-Tenatumomab Treatment in Tenascin-C Positive Cancer Patients	NCT02602067	Breast Neoplasm Head and Neck N... Skin Neoplasm Respiratory Tra... Urogenital Neop... Digestive Syste... Pancreatic Neop... Connective and ... Lymphoma, Non-H...	131I-Tenatumoma...	18 Years - 75 Years	sigma-tau i.f.r. S.p.A.
131Iodine-Tenatumomab Treatment in Tenascin-C Positive Cancer Patients	NCT02602067	Breast Neoplasm Head and Neck N... Skin Neoplasm Respiratory Tra... Urogenital Neop... Digestive Syste... Pancreatic Neop... Connective and ... Lymphoma, Non-H...	131I-Tenatumoma...	18 Years - 75 Years	sigma-tau i.f.r. S.p.A.

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