This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.
Study Type
OBSERVATIONAL
Enrollment
4
HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg
Fudan University Shanghai Cancer Center
Shanghai, China
Dose limiting toxicity (DLT)
The proportion of patients experiencing dose limiting toxicities
Time frame: up to 24 weeks
Objective response rate (ORR)
ORR as assessed by the investigator according to RECIST 1.1
Time frame: through study completion, an average of 1 year
Duration of response (DOR)
clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria
Time frame: through study completion, an average of 1 year
Progression free survival (PFS) rates
Progression free survival (PFS) rates
Time frame: 6 months and 12 months
Overall survival (OS)
Overall survival (OS) rates
Time frame: 6 months and 12 months
Clinical benefit rate (CBR)
Clinical benefit rate
Time frame: CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks
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