Solid tumors Solid tumors
Conditions
Interventions
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
Antibodies, Monoclonal
Ganglioside Nglicolil GM3
Antibodies Monoclonal 14F7
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernández
National Center for Clinical Trials Coordination
Outcome results
None listed