131Iodine-Tenatumomab Treatment in Tenascin-C Positive Cancer Patients (Tenatumomab)
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|ClinicalTrials.gov Identifier: NCT02602067|
Recruitment Status : Terminated (Uptake of drug into the tumour lesion was negligible)
First Posted : November 11, 2015
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Combination Product: 131I-Tenatumomab||Phase 1|
This will be an open-label dose escalation study. The study will be conducted in two steps:
- STEP A aims to identify the optimal amount of antibody to convey the specific radio-label activity of radionuclide.
- 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
- To identify the Maximum Tolerated Dose (MTD) and assess Safety and Tolerability of i.v. infused 131I-Tenatumomab.
- To identify the optimal amount of unlabeled Tenatumomab able to convey 131I- Tenatumomab with the highest Tumor/nonTumor ratio.
- 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.
- To evaluate intra-lesional distribution and retention of 131I-Tenatumomab and to record individual lesion dosimetry.
- To evaluate systemic biodistribution, pharmacokinetics, urinary excretion and dose linearity of 131I-Tenatumomab.
- To evaluate proportional 131I-Tenatumomab tumor binding, as a function of the total load.
- To evaluate Pharmacokinetics of Tenatumomab (protein and protein related materials) in serum.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Tenatumomab infusion|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||April 30, 2017|
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)
Combination Product: 131I-Tenatumomab
I131anti-Tenascin monoclonal antibody administered to be targeted on neoplasms expressing Tenascin-C
Other Name: Tenatumomab/ST2146
- Dose Limiting Toxicity evaluated using NCI Common Toxicity Criteria (CTCAE 4.03) [ Time Frame: up to six weeks ]no more details necessary
- Adverse Events [ Time Frame: up to 1 year ]no more details necessary
- Tumor response [ Time Frame: 1 year ]Tumor response according to Response Evaluation Criteria in Solid Tumors RECIST V 1.1 or PERCIST
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602067
|Bordeaux, France, 33076|
|Centre Leon Berard|
|Lyon, France, 69373|
|Icm Val D'Aurelle|
|Montpellier, France, 34298|
|Istituto Nazionale Dei Tumori Irccs - Fondazione "G. Pascale"|
|Naples, Italy, 80131|
|University of Study of Pisa|
|Pisa, Italy, 65126|
|S. Maria Nuova Hospital - Irccs|
|Reggio Emilia, Italy, 42123|
|Humanitas Clinical Institute|
|Rozzano Mi, Italy, 20089|
|Study Chair:||SECONDO LASTORIA, M.D.||ISTITUTO NAZIONALE DEI TUMORI IRCCS - FONDAZIONE "G. PASCALE" NAPLES - ITALY|