Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer

Terminated

• Conditions: HER2-positive Metastatic Breast Cancer
• Interventions: Drug: KN026 combined with Palbociclib and Fulvestrant

• Registration Number: NCT04778982
• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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.

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-03
• Study Start: 2022-05-25
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
parallel-group expansion Phase	KN026 combined with Palbociclib and Fulvestrant	KN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC )

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	through study completion, an average of 1 year	ORR as assessed by the investigator according to RECIST 1.1
Dose limiting toxicity (DLT)	up to 24 weeks	The proportion of patients experiencing dose limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS) rates	6 months and 12 months	Progression free survival (PFS) 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
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
Overall survival (OS)	6 months and 12 months	Overall survival (OS) rates

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China