A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 25, 2021

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Metastatic CancerSoft Tissue SarcomaMerkel Cell CarcinomaMelanomaTriple Negative Breast CancerNon Small Cell Lung Cancer
Interventions
BIOLOGICAL

BT-001

Oncolytic Vaccinia virus containing genes encoding the 4-E03 human recombinant anti-hCTLA4 antibody and human GM-CSF administered at different dose \[Phase I, Part A\]; one dose lower and at Recommended Dose for Part B \[Phase I, Part B\] by intra-tumoral (IT) route.

DRUG

Pembrolizumab [KEYTRUDA®]

Programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks.

Trial Locations (5)

1200

RECRUITING

Clinique Universitaire Saint-Luc, Brussels

33000

RECRUITING

Institut Bergonié, Bordeaux

69008

RECRUITING

Centre Léon Bérard, Lyon

75010

RECRUITING

Hôpital Saint-Louis AP-HP, Paris

94800

RECRUITING

Institut Gustave Roussy, Villejuif

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

BioInvent International AB

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Transgene

INDUSTRY