A Phase II Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Locally Advanced HER2-positive Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- KN026 combined with Palbociclib and Fulvestrant
- Conditions
- HER2-positive Metastatic Breast Cancer
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Dose limiting toxicity (DLT)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
parallel-group expansion Phase
KN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC )
Intervention: KN026 combined with Palbociclib and Fulvestrant
Outcomes
Primary Outcomes
Dose limiting toxicity (DLT)
Time Frame: up to 24 weeks
The proportion of patients experiencing dose limiting toxicities
Objective response rate (ORR)
Time Frame: through study completion, an average of 1 year
ORR as assessed by the investigator according to RECIST 1.1
Secondary Outcomes
- Progression free survival (PFS) rates(6 months and 12 months)
- Clinical benefit rate (CBR)(CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks)
- Duration of response (DOR)(through study completion, an average of 1 year)
- Overall survival (OS)(6 months and 12 months)