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
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.
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