The study will evaluate the safety and efficacy of QLC5513 alone or in combination with QL1706 in patients with advanced or metastatic triple-negative breast cancer (TNBC) who had received ≥1 line of prior systematic therapy.
This is a Phase 2, randomized, open-label study. TNBC patients eligible for inclusion will be randomly assigned (1:2) to receive either QLC5513 alone (Arm 1) or QLC5513 plus QL1706 (Arm 2). After the completion or discontinuation of the study treatment, safety follow-up and survival follow-up will be performed. The primary objective is to evaluate the objective response rate (ORR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants of Arm A will receive QLC5513 16 mg/kg intravenously on day 1 and day 8 every 3 weeks. QLC5513 is a Trop2-targeting ADC with a proprietary stable linker and an SN38 cytotoxic payload.
Participants of Arm B will receive QLC5513 16 mg/kg intravenously on day 1 and day 8 every 3 weeks and QL1706 5 mg/kg intravenously on day 1 every 3 weeks. QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD1 IgG4 and anti-CTLA4 IgG1 antibodies.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
refers to the period from the start of treatment to disease progression or death from any cause, whichever occurred first, or last PFS assessment for patients alive without progression.
Time frame: Up to approximately 2 years
Duration of Response (DoR)
the time from the first documented evidence of complete response (CR) or partial response (PR) until the first date of documented disease progression or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, or stable disease to a therapeutic intervention in a clinical trial.
Time frame: Up to approximately 2 years
Overall survival (OS)
Refers to the period from the moment of random assignment to the date of death for any reason.
Time frame: Up to approximately 2 years
Number of Participants With Adverse Events (AEs)
Refers to the incidence and grade of adverse events (AE) and severe adverse events (SAE); AE is assessed according to the National Cancer Institute Common Toxicity Grading Criteria (NCI-CTCAE) version 5.0.
Time frame: Up to approximately 2 years
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