Dose scale-up and cohort expansion with the therapeutic mAb 14F7

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.

Scientific title:

Dose scale-up and cohort expansion study with the therapeutic mAb 14F7 (Anti-Nglicolil GM3) in patients with solid tumors at advanced stages

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center of 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 Drugs, Medical Devices and Equipment (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:

Marta

Last name:

Osorio Rodriguez

Medical Specialty :

Second Degree Specialist in Oncology

Affiliation:

National Institute for Oncology and Radiobiology (INOR)

Postal address:

Calle 29, esquina F, Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382590

Email address:

mosorio@infomed.sld.cu

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:

National Institute for Oncology and Radiobiology (INOR), October 26th, 2015

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/01/2016

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:

Solid tumors

Health condition(s) code:

Neoplasms

Health condition keyword:

Solid tumors

Intervention(s):

AcM 14F7 mAb intravenously in 5 dose levels (10 mg, 25 mg, 50 mg, 100 mg o 200 mg), quarterly during first two months (5 doses) and them as maintenance schedule every 28 days until complete six months (4 doses).

Intervention code:

G(M3) Ganglioside

Gangliosides

Antibodies, Monoclonal

Antibodies

Immunoglobulins

Intervention keyword:

Ganglioside Nglicolil GM3 Antibodies Monoclonal 14F7

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):

Serious Adverse Events with causality relationship (Will be considered Serious Adverse Events those that: 1. Produce death, 2. life-threatening, 3. hospitalization or prolongation of hospitalization indicated, 4. Produce disability / persistent or significant disability, 5. Produce birth defect or congenital anomaly. Will be consider causality relationship when the SAE has definitive/highly probable or probable causality). Measuring time: from the administration of the first dose until 30 days after the last dose of 14F7

Key secondary outcomes:

Objective response (Classified as complete, partial, stable or progressive disease according to Response Evaluation Criteria in Solid Tumor-RECIST). Measuring time: month 3, 7 and 12 Immunogenicity HAMA/HAHA response (Yes, No. It will be "Yes" when the value of the density of the patient serum is greater than 2 standard deviations of the value of the sera of healthy donor). Measuring time: prior to enrollment, prior to each administration MAb 14F7hT and 12 months. Potential biomarkers Ganglioside detection NGGM3 (Yes or No). Measurement time before the first dose of MAb 14F7hT Pharmacokinetic parameters Serum concentration of the MAb 14F7hT (numeric value). Measuring time: at each administration of MAb 14F7hT Maximum concentration of the MAb 14F7hT (numeric value). Measuring time: at each administration of MAb 14F7hT Half-life of the MAb 14F7hT (numeric value). Measuring time: at each administration of MAb 14F7hT Plasma clearance of the MAb 14F7hT (numeric value). Measuring time: at each administration of MAb 14F7hT

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. Have histologically and/or cytologically confirmed diagnosis of advanced solid tumor 2. Aged >18 years 3. Laboratory parameteres: Hemoglobin ≥ 9 g/L, White blood cell (WBC) count ≥ 3000/ μL, Neutrophils count ≥ 1500/μL, Platelet count ≥ 100,000/μL, Total bilirrubin: Within normal limits for each institution, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the institutional upper limit of normal, Creatinine ≤ 1.5 times the institutional upper limit of normal. 4. Life expectancy at least 3 months 5. Agree to use double-barrier contraception (males and females alike [if applicable]). 6. A negative pregnancy test must be documented at Screening for females of childbearing potential. 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status 0; 1 or 2. 8. Response to onco-specific first-line treatment for advanced disease according to RECIST evaluated as complete response, partial or stable disease.

Exclusion criteria:

1. Patient is currently enrolled in other investigational drug trial. 2. Patients with a history of allergies attributed to compounds of chemical or biological composition to 14F7 or similar to other agents used in the study. 3. Patient has an unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease). 4. Pregnant or nursing women. 5. Another active concurrent malignant disease except non- melanoma skin lesions or cervix cancer. 6. Patients with CNS metastases. (Only if detectable by radiological image scan previous sign or symptoms)

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:

Treatment

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Dose scale-up with cohort expansion

Phase:

1

Target sample size:

60

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:

Ivis

Last Name:

Mendoza Hernández

Specialty:

MSc. Bachellor in Farmacy

Affiliation:

National Center for Clinical Trials Coordination

Postal Address:

5ta A / 60 y 62 Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+537-216-4227

Email :

ivis@cencec.sld.cu

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:

Yanelda

Middle Name:

de los Angeles

Last Name:

García Vega

Specialty:

Degree in Biochemistry. MSc in Clinical Laboratory Sciences

Affiliation:

Center of Molecular Immunology

Postal Address:

216 & 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

16040

Telephone:

+537 271-7933 Ext 3449

Email :

yaneldag@cim.sld.cu

camilo@cim.sld.cu

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:

RPCEC00000204

Date of Registration in Primary Registry:

04/12/2015

Record Verification Date:

2015/12/04

Next update date:

2016/12/04

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

Dose scale-up and cohort expansion with the therapeutic mAb 14F7

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