A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

February 24, 2020

Primary Completion Date

December 10, 2024

Study Completion Date

February 14, 2025

Conditions
HER2-positive Solid TumorsHER2-positive Breast CancerHER2-positive Colorectal CancerHER2-positive Gastroesophageal CancerHER2-positive Endometrial Cancer
Interventions
DRUG

BDC-1001

Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

DRUG

Nivolumab

Programmed death receptor-1 (PD 1)-blocking antibody

Trial Locations (21)

10065

Memorial Sloan-Kettering Cancer Center, New York

13009

Institut Paoli Calmettes, Marseille

13620

Seoul National University Bundang Hospital, Seongnam-si

20007

Georgetown University Medical Center, Washington D.C.

22031

Virginia Cancer Specialists, Fairfax

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28204

Levine Cancer Institute, Charlotte

33076

Institut Bergonie, Bordeaux

49546

START Midwest, Grand Rapids

60637

The University of Chicago Medical Center, Chicago

73104

Stephenson Cancer Center, Oklahoma City

77030

The University of Texas MD Anderson Cancer Center, Houston

78229

South Texas Accelerated Research Therapeutics, San Antonio

94304

Stanford University, Palo Alto

94805

Institut Gustave Roussy, Villejuif

02215

Dana-Farber Cancer Institute, Boston

06351

Samsung Medical Center, Seoul

05505

Asan Medical Center, Seoul

08003

Hospital del Mar, Barcelona

08035

Hospital Universitario Vall d'Hebron, Barcelona

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Bolt Biotherapeutics, Inc.

INDUSTRY

NCT04278144 - A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors | Biotech Hunter | Biotech Hunter