QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

May 7, 2024

Primary Completion Date

November 7, 2025

Study Completion Date

November 7, 2030

Conditions
Early Breast CancerNeoadjuvant TherapyTNBC, Triple Negative Breast Cancer
Interventions
DRUG

Bispecific antibody (bsAb) targeting PD-1 and CLTA-4

QL1706 is a novel bispecific combination antibody composed of a recombinant humanized IgG4 monoclonal antibody targeting human PD-1 (programmed cell death protein 1) (PSB103) and a recombinant humanized IgG1 monoclonal antibody targeting human CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) (PSB105). Both antibodies have undergone engineering modifications to introduce mutations facilitating their correct assembly and preventing mispairing, and are expressed in the same cell line at a predetermined ratio (approximately 2:1).

DRUG

Albumin-bound paclitaxel

Albumin-bound paclitaxel improves the solubility and delivery of paclitaxel to tumor cells by binding to human albumin, facilitating its transportation through the bloodstream and enhancing its uptake into tumor tissue. It works by binding to and stabilizing microtubules within cancer cells, thereby disrupting the normal process of cell division and leading to cell cycle arrest and apoptosis, ultimately resulting in the death of cancer cells.

DRUG

Carboplatin

Carboplatin is a chemotherapy medication belonging to the platinum-based class of drugs, commonly used in the treatment of various cancers, including ovarian cancer, lung cancer, and bladder cancer. It functions by forming DNA adducts, disrupting DNA replication and transcription processes in cancer cells, ultimately leading to cell death. Despite its efficacy, carboplatin can cause side effects such as nausea, vomiting, and bone marrow suppression.

Trial Locations (1)

200032

Zhimin Shao, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER

NCT06404736 - QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer | Biotech Hunter | Biotech Hunter