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

NCT02602067 | Terminated Phase 1 DMC

• 2 other identifiers: TENATUMOMAB/ST2146-CR-14-0012014-003832-38
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 7

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity evaluated using NCI Common Toxicity Criteria (CTCAE 4.03)

  no more details necessary

  up to six weeks

Secondary Outcomes (1)

• Adverse Events

  up to 1 year

Other Outcomes (1)

• Tumor response

  1 year

Study Arms (1)

131I-Tenatumomab

EXPERIMENTAL

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

Interventions

131I-Tenatumomab COMBINATION_PRODUCT

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

Also known as: Tenatumomab/ST2146

131I-Tenatumomab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Written informed consent.
• \. A patient who has (a) a histologically documented advanced tumor that has relapsed from, or is refractory to, standard treatment and for which no other standard treatment is available and (b) confirmed Tenascin-C expression obtained through a biopsy on at least one reachable tumor lesion.
• These patients will have failed one or more prior therapeutic line and had assessable and measurable disease expression, but were not considered eligible for other standard approaches with curative intent, as assessed by the Investigator.
• \. Agreement to hemopoietic stem cell collection procedures (the procedure will be performed upon clinical evaluation of the Investigator and if deemed necessary in the interest of the patient).
• \. Male or female ≥18 years of age
• \. Eastern Cooperative Oncology Group (ECOG), or WHO performance status of ≤ 2 or Karnofsky \> 60
• \. Life expectancy of at least 3 months.
• \. Negative pregnancy test for all women of child-bearing potential. Appropriate contraception (one highly effective method or a combination of acceptable methods) is to be used during the study period and until 90 days after the last follow-up visit (End of Study Visit)
• \. Hematological, thyroid, liver, cardiac and renal function test results ≤ grade 2 toxicity (according to US National Cancer Institute's "Common Terminology Criteria for Adverse Events v4.03 \[CTCAE\]"), e.g.:
• Haematology:
• Hematocrit ≥ 30%
• Hemoglobin ≥ 9.0 g/dl
• White blood cell count ≥ 3 x 109/L
• Neutrophils \> 1.5 x109/L
• Platelets ≥ 100x 109/L

You may not qualify if:

• \. Known hypersensitivity to Tenatumomab, Iodine or any excipient.
• \. Active infection at screening or history of severe infection within the previous 2 months, if considered clinically relevant by the Investigator.
• \. Positive test to Human Immunodeficiency Virus (HIV) and/or chronically active Hepatitis B or C.
• \. Patients with primary Central nervous system tumor or cerebral metastases.
• \. Administration of another investigational medicinal product within 45days before the screening period.
• \. Previous treatment with any radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used prior to the administration of study drug.
• \. History of somatic or psychiatric disease/condition that may interfere with the objectives of the study.
• \. Major illness, trauma, or surgery within 2 weeks before the screening period, if considered clinically significant by the Investigator.
• \. Patient who underwent chemotherapy and/or radiation therapy and/or treatments with biologics (which are not to be of murine origin) within 4 weeks before the screening period.
• \. Women who are breast feeding, due to the potential risk of damage to the infant.
• \. Men unwilling to use appropriate contraceptive methods during the study and up to 90 days after the last follow-up visit (End of Study Visit).
• \. Bladder catheterization cannot be performed, or the patient is unwilling to be catheterized if necessary.
• \. Murine antibodies treated patients. It is at the discretion of the Investigator to exclude patients who have worsened considerably from screening to Day -1.

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.: lead
• Medpace, Inc.: collaborator

Study Sites (7)

Institut Bergonnie

Bordeaux, 33076, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Icm Val D'Aurelle

Montpellier, 34298, France

Location

Istituto Nazionale Dei Tumori Irccs - Fondazione "G. Pascale"

Naples, 80131, Italy

Location

University of Study of Pisa

Pisa, 65126, Italy

Location

S. Maria Nuova Hospital - Irccs

Reggio Emilia, 42123, Italy

Location

Humanitas Clinical Institute

Rozzano MI, 20089, Italy

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Thoracic Neoplasms; Respiratory Tract Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplasms by Histologic Type; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• SECONDO LASTORIA, M.D.

  ISTITUTO NAZIONALE DEI TUMORI IRCCS - FONDAZIONE "G. PASCALE" NAPLES - ITALY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Tenatumomab infusion

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: September 18, 2018

Record last verified: 2018-01

Locations

FR (3); IT (4)