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

HER2-positive Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04778982
• Other study ID #: KN026-205
• Status: Terminated
• Start date: May 25, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: July 2023
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Metastatic Breast Cancer

Intervention

Drug:
• KN026 combined with Palbociclib and Fulvestrant
HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)	The proportion of patients experiencing dose limiting toxicities	up to 24 weeks
Primary	Objective response rate (ORR)	ORR as assessed by the investigator according to RECIST 1.1	through study completion, an average of 1 year
Secondary	Duration of response (DOR)	clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria	through study completion, an average of 1 year
Secondary	Progression free survival (PFS) rates	Progression free survival (PFS) rates	6 months and 12 months
Secondary	Overall survival (OS)	Overall survival (OS) rates	6 months and 12 months
Secondary	Clinical benefit rate (CBR)	Clinical benefit rate	CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD =24 weeks