This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.
This is a multi-center, open-label, phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of SKB103 in participants with locally advanced, recurrent or metastatic HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
SKB103 for injection, administered as monotherapy via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks, Q3W). Treatment continues until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death, whichever occurs first.
Number of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as any adverse event (AE) that meets protocol-defined DLT criteria, occurring in the first 21 days, and considered at least possibly drug-related.
Time frame: Within the first 21 days following the initial dose.
Objective response rate(ORR)
ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as the best overall response assessed per RECIST 1.1.
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
PFS is defined as the time from the first dose to progressive disease (PD) or death, whichever occurs first. PD will be assessed per RECIST 1.1.
Time frame: Up to approximately 3 years
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in participants to PD or death due to any reason.
Time frame: Up to approximately 3 years
Disease control rate (DCR)
DCR is defined as the proportion of participants with CR, PR or stable disease (SD) as the best overall response assessed per RECIST 1.1.
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time from start of treatment to death due toany reason.
Time frame: Up to approximately 3 years
Cmax
Maximum Plasma Concentration (Cmax) of SKB103-ADC, SKB103-TAB, and free KL610348.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to approximately 3 years
Cmin
Minimum Observed Plasma Concentration (Cmin) of SKB103-ADC, SKB103-TAB, and free KL610348.
Time frame: Up to approximately 3 years
Immunogenicity
Presence of Anti-drug antibodys (ADAs) for SKB103
Time frame: Up to approximately 3 years