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):
Clinical Adverse Events (AE). Measuring time: week 1, when initiating the administration of anti-tumor candidate CIGB-370, before each administration (during the first 4 weeks of treatment) and at weeks 5 to 8. The adverse events will be measured like:
-Appearance of AE (Yes, No)
-Description of AE (name of the event)
-Intensity of EA (mild, moderate, severe)
Laboratory tests (numerical values of hematology and biochemistry). Measuring time: at baseline, week 5, and week 8.
Key secondary outcomes:
Pharmacokinetics of CIGB-370 polypeptide (i n serum). Measuring time: before administration CIGB-370, at 15 and 30 minutes post-infusion i n hours 1, 2, 3, 5, 7, 12, 16, 24, 36 and 48, and on days 7, 15, 21 and 28 post-treatment initiation.
Immune response (titer determination of anti-bodies anti -CIGB370). Measuring time: Days 7, 15, 21 and 28.
Identifying target polypeptide CIGB-370 tumor markers (plasma, qualitatively by co-immunoprecipitation method). Measuring time: at baseline, week 8.
Quality of life (EORTC QLQ-C30 survey: worsened, unchanged, slightly improved, moderately improved, and much improved). Measuring time: at baseline, week 8.
Tumor response (RECIST version 1.1: Complete response, Partial response, Stable Disease, Progressive disease). Measuring time: week 8.