NCT06404736

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

A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk TNBC Early-Stage Breast Cancer (QUEEN-Dream)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel and carboplatin in a neoadjuvant setting, in high-risk, TNBC early breast cancer.

Detailed description

This study is a single-arm, single-center, phase II clinical study designed to observe and evaluate the efficacy and safety of QL1706 combined with Pcb regimen in the neoadjuvant treatment of early-stage high-risk TNBC breast cancer. It is planned to enroll 73 subjects. After the subjects are enrolled in the study, they will receive 6 cycles of QL1706 combined with PCb regimen. A 3-week treatment cycle is used until the treatment termination event specified in the protocol occurs. The subjects will continue to undergo postoperative efficacy and safety visits after ending of the treatment.

Conditions

• Early Breast Cancer
• Neoadjuvant Therapy
• TNBC, Triple Negative Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-07
• Primary completion: 2025-11-07
• Completion: 2030-11-07
• First posted: 2024-05-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: China