A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

PHASE1TerminatedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

January 3, 2019

Primary Completion Date

July 25, 2022

Study Completion Date

February 21, 2024

Conditions
Metastatic Neoplasm
Interventions
DRUG

SAR441000

"Pharmaceutical form: concentrate for solution for injection~Route of administration: intratumoral"

DRUG

Cemiplimab REGN2810

"Pharmaceutical form: solution for injection~Route of administration: intravenous"

Trial Locations (19)

1200

Investigational Site Number : 0560001, Brussels

3000

Investigational Site Number : 0560002, Leuven

9000

Investigational Site Number : 0560003, Ghent

13885

Investigational Site Number : 2500004, Marseille

20246

Investigational Site Number : 2760005, Hamburg

31008

Investigational Site Number : 7240001, Pamplona

44195

Cleveland Clinic - Cleveland- Site Number : 8400007, Cleveland

46014

Investigational Site Number : 7240002, Valencia

55131

Investigational Site Number : 2760001, Mainz

68167

Investigational Site Number : 2760003, Mannheim

69120

Investigational Site Number : 2760004, Heidelberg

72076

Investigational Site Number : 2760006, Tübingen

75010

Investigational Site Number : 2500002, Paris

77030

The University of Texas MD Anderson Cancer Center- Site Number : 8400002, Houston

94805

Investigational Site Number : 2500001, Villejuif

02215

Dana-Farber Cancer Institute- Site Number : 8400003, Boston

6525 GA

Investigational Site Number : 5280002, Nijmegen

3015 CE

Investigational Site Number : 5280001, Rotterdam

08036

Investigational Site Number : 7240004, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

BioNTech RNA Pharmaceuticals GmbH

INDUSTRY

lead

Sanofi

INDUSTRY