HER2-positive Metastatic Breast Cancer
Conditions
Keywords
KN026, palbociclib, HER2-positive MBC
Brief summary
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.
Detailed description
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.
Interventions
DRUGKN026 combined with Palbociclib and Fulvestrant
HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subject \>= 18 years; * Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive; * Adequate organ function assessed within 7 days prior to first trial treatment * ECOG score 0 or 1; * Left ventricular ejection fraction (LVEF) ≥ 50% at baseline; * Life expectancy \>3 months
Exclusion criteria
* Untreated active CNS metastasis or leptomeningeal metastasis; * Uncontrolled tumor-related pain; * Has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment; * Major surgery for any reason within 28 days; * Curative radiation within 3 months of the first dose of trial treatment; * History of uncontrolled intercurrent illness; * Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) | up to 24 weeks | The proportion of patients experiencing dose limiting toxicities |
| Objective response rate (ORR) | through study completion, an average of 1 year | ORR as assessed by the investigator according to RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | through study completion, an average of 1 year | clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria |
| Progression free survival (PFS) rates | 6 months and 12 months | Progression free survival (PFS) rates |
| Overall survival (OS) | 6 months and 12 months | Overall survival (OS) rates |
| Clinical benefit rate (CBR) | CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks | Clinical benefit rate |
Countries
China
Outcome results
None listed