A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

161

Participants

Timeline

Start Date

June 9, 2017

Primary Completion Date

December 21, 2021

Study Completion Date

January 17, 2022

Conditions
Malignant Solid Tumor
Interventions
BIOLOGICAL

SAR439459

"Pharmaceutical form: powder for solution for infusion~Route of administration: intravenous infusion"

DRUG

Cemiplimab REGN2810

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

Trial Locations (34)

704

Investigational Site Number : 1580002, Tainan City

3000

Investigational Site Number : 0360001, Melbourne

Investigational Site Number : 0560001, Leuven

3081

Investigational Site Number : 0360002, Heidelberg West

13385

Investigational Site Number : 2500002, Marseille

13419

Investigational Site Number : 2330001, Tallinn

20089

Investigational Site Number : 3800003, Rozzano

20133

Investigational Site Number : 3800001, Milan

20141

Investigational Site Number : 3800002, Milan

27710

Duke University Medical Center Site Number : 8400008, Durham

28040

Investigational Site Number : 7240003, Madrid / Madrid

28050

Investigational Site Number : 7240004, Madrid / Madrid

30625

Investigational Site Number : 2760003, Hanover

31008

Investigational Site Number : 7240005, Pamplona

37203

Tennessee Oncology, PLLC Site Number : 8400006, Nashville

44093

Investigational Site Number : 2500003, Nantes

Investigational Site Number : 2500005, Nantes

45122

Investigational Site Number : 2760001, Essen

66205

The University of Kansas Clinical Research Center Site Number : 8400004, Fairway

75230

Mary Crowley Cancer Research Center Site Number : 8400003, Dallas

94800

Investigational Site Number : 2500001, Villejuif

02114

Massachusetts General Hospital Site Number : 8400001, Boston

02115

Dana Farber Cancer Institute Site Number : 8400101, Boston

T2N 4N2

Investigational Site Number : 1240003, Calgary

M5G 2M9

Investigational Site Number : 1240001, Toronto

H3T 1E2

Investigational Site Number : 1240002, Montreal

3015 GD

Investigational Site Number : 5280001, Rotterdam

3584 CX

Investigational Site Number : 5280002, Utrecht

03080

Investigational Site Number : 4100001, Seoul

138-736

Investigational Site Number : 4100002, Seoul

08003

Investigational Site Number : 7240002, Barcelona

08035

Investigational Site Number : 7240001, Barcelona

G12 0YN

Investigational Site Number : 8260001, Glasgow

CF14 2TL

Investigational Site Number : 8260002, Cardiff

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT03192345 - A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter