Dose scale-up and cohort expansion with the therapeutic mAb 14F7
- Conditions
- Solid tumorsNeoplasms
- Registration Number
- RPCEC00000204
- Lead Sponsor
- Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method