Nimotuzumab cold kit for the immunodiagnosis of solid tumors

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

Nimo kit

Scientific title:

Efficacy and safety of cold kit of monoclonal antibody nimotuzumab labeled with 99mTc for the immunodiagnosis of head and neck tumors, lung and gliomas

Acronym of Scientific Title:

Nimo cold kit

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center for Molecular Immunology (CIM) Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Juan

Midle name:

Felipe

Last name:

Batista Cuellar

Medical Specialty :

1st Degree Specialist in Internal Medicine. Nuclear Physician.

Affiliation:

Isotope Center (CENTIS) - Clinical Research Center (CIC)

Postal address:

Street 45, number 4501, corner to 34, Kholy

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72030087

+53-72023763

+53-72027055

Email address:

batista@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Clinical Research Center (CIC), In review

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

30/09/2019

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Tumors of head and neck, lung and gliomas

Health condition(s) code:

Head and Neck Neoplasms

Lung Neoplasms

Glioma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Neuroepithelia

Neoplasms, Glandular and Epithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroectodermal Tumors

Intervention(s):

Group I- MAb Nimotuzumab 3mg (Experimental). Immunoscintigraphy with the radioimmunoconjugate 99mTc-hR3 (3 mg of the Monoclonal Antibody Nimotuzumab from the cold kit, marked with 35-40 mCi of 99mTc) by intravenous route. Group II – MAb Nimotuzumab 6mg (Experimental). Immunoscintigraphy with the radioimmunoconjugate 99mTc-hR3 (6 mg of Nimotuzumab Monoclonal Antibody from the cold kit, labeled with 35-40 mCi of 99mTc) by intravenous route.

Intervention code:

Antibodies, Monoclonal, Humanized

Antibodies, Monoclonal

Radionuclide Imaging

Immunoscintigraphy

Immunologic Tests

Radioimmunodetection

Immunoconjugates

Administration, Intravenous

Intervention keyword:

Nimotuzumab

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Degree of graphic gamma positivity (InGG immunography will be performed to determine the degree of concordance, sensitivity, specificity, positive predictive value, negative predictive value). Measurement time: at 4 and 18-24 hours after the administration of Radioimmunoconjugate. 2. Overexpression of the EGFR (overexpression of EGFR in the biopsy as High, Moderate, Low, Negative). Measurement time: At baseline.

Key secondary outcomes:

Adverse events (Incidence of Adverse Events (AE) reported by the patient and by laboratory tests measured as: Occurrence of any AE (Yes, No); Description of the AE (Name of the adverse event); Duration of the AE (Difference between the start and end date of the AE); Intensity of the AE (Light, Moderate, Severe, AE that threatens or incapacitates and AE that causes death); Severity of the AE (Serious, Not serious); Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or squeal], Causal relationship (1. Definitive 2. Very probable, 3. Probable, 4. Possible, 5. Unrelated 6. Unknown)). Measurement time: 28 days after administration

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients who have signed the informed consent. 2. Patients that meet the diagnostic criteria. 3. Patients with biopsy samples that allow IHC study of overexpression of EGFR, imaging study and clinical documentation to corroborate the existence of the lesions. 4. Patients of both sexes older than 18 years. 5. Patients with life expectancy of 3 months or more. 6. Patients with functional status according to the ECOG scale ≤ 2, (Eastern Cooperative Oncology Group) ECOG. 7. Patients with functioning of organs and bone marrow defined by the following parameters: Hemoglobin greater than or equal to 90 g / L. Total leukocyte count greater than or equal to 3.0 x 109 / L Platelet count greater than or equal to 100 x 109 / L. Bilirubin: Within normal limits for each institution Glycemia Within normal limits for each institution ALP: up to 2.5 times the normal upper limit for each institution. LDH: Within normal limits for each institution GOT/GPT: up to 2.5 times the normal upper limit for each institution. Creatinine: Within normal limits for each institution.

Exclusion criteria:

1. Patients with acute allergic states, history of severe allergic reactions or autoimmune diseases. 2. Patients who are receiving another product under investigation. 3. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the monoclonal antibody. 4. Patients with uncontrolled intercurrent diseases, including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illnesses that could limit adherence to trial requirements. 5. Female patients who are pregnant, nursing.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Diagnostic

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Dose escalation

Phase:

1-2

Target sample size:

26-30

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mayelin

Last Name:

Troche Concepcion

Specialty:

MSc. Clinical Trials, Bachelor's degree in nursing

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

16040, Box 11600

Telephone:

+53-72143144

Email :

mayelin@cim.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mayelin

Last Name:

Troche Concepcion

Specialty:

MSc. Clinical Trials, Bachelor's degree in nursing

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

16040, Box 11600

Telephone:

+53-7214 3144

Email :

mayelin@cim.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000290

Date of Registration in Primary Registry:

05/10/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here [3]