This study will consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Administered intravenously
Administered intravenously
EDOG - Institut Bergonie - PPDS
Bordeaux, France
EDOG Institut de Cancerologie de l'Ouest - PPDS
Nantes, France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes, France
Frequency of TEAEs (Treatment-emergent adverse events)
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Number of participants with DTLs (dose-limiting toxicities)
Time frame: Up to day 28
Number of subjects with 1 or more TEAEs leading to dose modifications
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Number of subjects with grade ≥ 3 TEAEs
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Percentage of subjects with grade ≥ 3 TEAEs
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Number of subjects with 1 or more TEAEs leading to treatment discontinuation
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Percentage of subjects with 1 or more TEAEs leading to dose modification
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
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Institut de Cancerologie de l'Ouest
Saint-Herblain, France
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON
Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
START MADRID_Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Number of subjects with 1 or more SAEs (serious adverse events)
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Percentage of subjects with 1 or more SAEs
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Serum Concentrations of CAN04 and Folfirnox
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Antidrug antibodies (ADAs) against CAN04
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Change in serum IL-6 (Interleukin-6) concentration
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Change in serum CRP (C-reactive protein) concentration
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Overall response rate (ORR)
Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI Scan)
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Progression free survival
Time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first.
Overall Survival
Time frame: Up to 36 months after 1st dose of last subject (or death)