Trials / Terminated
TerminatedNCT02602067
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- sigma-tau i.f.r. S.p.A. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
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
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | 131I-Tenatumomab | I131anti-Tenascin monoclonal antibody administered to be targeted on neoplasms expressing Tenascin-C |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2017-04-30
- Completion
- 2017-04-30
- First posted
- 2015-11-11
- Last updated
- 2018-09-18
Locations
7 sites across 2 countries: France, Italy
Source: ClinicalTrials.gov record NCT02602067. Inclusion in this directory is not an endorsement.