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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
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).
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.
Zhimin Shao
Shanghai, Not US/Canada, China
Total Pathological complete response (tpCR) rate using the definition of ypT0/Tis, N0
No invasive residual in breast or nodes; noninvasive breast residuals allowed ) at the time of definitive surgery
Time frame: Up to approximately 36 weeks after study start
pCR rate using an alternative definition, ypT0/Tis
PCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.
Time frame: Up to approximately 36 weeks after study start
pCR rate in PD-L1+ population
pCR rate (ypT0/is ypN0) is defined as the percentage of participants without residual invasive on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in participants with tumors expressing Programmed Death-Ligand 1 (PD-L1).
Time frame: Up to approximately 36 weeks after study start
rate of RCB scored 0-1
Residual cancer burden scored at 0-1 on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy assessed by the local pathologist at the time of definitive surgery.
Time frame: Up to approximately 36 weeks after study start
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
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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.
Time frame: Up to approximately 36 weeks after study start