Unresectable locally advanced or metastatic colorectal cancer
Conditions
Brief summary
Primary end point for the Phase I: Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-Limiting Toxicities (DLT) (in dose escalation part), AEs leading to treatment discontinuation; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations, using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)., Primary endpoint for the Phase IIa: PFS rate at 12 months from STC-1010 IS treatment initiation, defined as the proportion of participants alive and without progression (i.e., participants with CR, PR or SD) at 12 months according to RECIST 1.1
Interventions
DRUGLeukine
DRUGOXALIPLATIN
DRUGENDOXAN 50 mg
DRUGcomprimé enrobé
DRUGSTC-1010
DRUGFLUOROURACIL
DRUGCALCIUM FOLINATE
Sponsors
Brenus Pharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point for the Phase I: Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-Limiting Toxicities (DLT) (in dose escalation part), AEs leading to treatment discontinuation; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations, using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)., Primary endpoint for the Phase IIa: PFS rate at 12 months from STC-1010 IS treatment initiation, defined as the proportion of participants alive and without progression (i.e., participants with CR, PR or SD) at 12 months according to RECIST 1.1 | — |
Countries
Belgium, France
Outcome results
None listed