Evaluation of Efficacy of Trifluridine/Tipiracil Plus an Anti-IL-1α True Human Antibody Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

October 13, 2022

Primary Completion Date

October 13, 2026

Study Completion Date

October 13, 2026

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

trifluridine/tipiracil + XB2001

trifluridine/tipiracil every 28 days + XB2001 1000mg intravenous infusion every 2 weeks

DRUG

trifluridine/tipiracil + placebo

trifluridine/tipiracil every 28 days + Placebo intravenous infusion every 2 weeks

Trial Locations (14)

11810

Centre Hospitalier Carcassonne, Carcassonne

21000

Centre Georges-François Leclerc, Dijon

CHU Dijon, Dijon

22190

Cario-Hpca, Plérin

25000

CHU Jean Minjoz, Besançon

33000

Institut Bergonié, Bordeaux

44000

CHU Nantes, Nantes

44805

Institut de Cancérologie de l'Ouest, Saint-Herblain

49055

ICO Angers, Angers

51100

Institut Jean Godinot, Reims

63003

CHU Estaing, Clermont-Ferrand

84000

Institut Sainte Catherine, Avignon

87000

CHU Dupuytren, Limoges

92300

Hopital Franco-Britannique, Levallois-Perret

All Listed Sponsors
lead

Centre Georges Francois Leclerc

OTHER