Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

November 30, 2023

Primary Completion Date

September 20, 2024

Study Completion Date

September 25, 2024

Conditions
Metastatic Breast CancerHER2-positive Breast Cancer
Interventions
DRUG

BDC-1001

BDC-1001 is an immune-stimulating antibody conjugate (ISAC) designed to be delivered systemically (intravenously) and act locally by targeting HER2-expressing tumors and related metastatic disease for destruction by the innate and adaptive immune systems. BDC-1001 consists of an investigational biosimilar of the humanized monoclonal antibody (mAb) trastuzumab that is chemically conjugated to a toll-like receptor (TLR)7/8 agonist (payload) with an intervening non-cleavable, cell membrane impermeable linker.

DRUG

Pertuzumab

Pertuzumab is a monoclonal antibody that targets HER2 and prevents dimerization of HER2 with other members of the HER family (HER1, HER3, and HER4), thereby blocking ligand-activated downstream signaling.

Trial Locations (4)

10065

Memorial Sloan Kettering Cancer Center, New York

22205

Virginia Cancer Specialists, Arlington

28041

Hospital Universitario 12 de Octubre, Madrid

92618

City of Hope, Irvine

Sponsors
All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Bolt Biotherapeutics, Inc.

INDUSTRY

NCT05954143 - Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter