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

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000204
• Date of registration: 04/12/2015
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Dose scale-up and cohort expansion with the therapeutic mAb 14F7
• 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
• Date of first enrolment: 01/01/2016
• Target sample size: 60
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000204-En
• Study type: Interventional
• Study design: Allocation: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Treatment
• Phase: 1

Countries of recruitment

Cuba

Contacts

• Name: Yanelda de los Angeles García Vega
• Affiliation: Center of Molecular Immunology

• Name: Ivis Mendoza Hernández
• Affiliation: National Center for Clinical Trials Coordination

Key inclusion & exclusion criteria

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)

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Solid tumors

Solid tumors
Solid tumors

Neoplasms

Intervention(s)

Ganglioside Nglicolil GM3
Antibodies Monoclonal 14F7

Antibodies, Monoclonal

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).

G(M3) Ganglioside

Immunoglobulins

Antibodies

Gangliosides

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

Secondary Outcome(s)

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

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable