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

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

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.

Study Overview

• Status: Terminated
• Conditions: HER2-positive Metastatic Breast Cancer
• Intervention / Treatment: Drug: KN026 combined with Palbociclib and Fulvestrant

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 Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

• Study Contact: Name: Jiong Wu, professor; Phone Number: 13601637369; Email: wujiong1122@vip.sina.com

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

diagnosing locally advanced unresectable or metastatic HER2-positive

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dose-escalation Phase; KN026 20 mg/kg + palbociclib125 mg/day+Fulvestrant 500 mg (Patients with HR+/HER2-positive MBC )
parallel-group expansion Phase; KN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC )	Drug: KN026 combined with Palbociclib and Fulvestrant; HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg; Other Names: combination

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS) rates	Progression free survival (PFS) rates	6 months and 12 months
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
Overall survival (OS)	Overall survival (OS) rates	6 months and 12 months
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

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: palbociclib; KN026; HER2-positive MBC
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protein Kinase Inhibitors; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant; Palbociclib
• Other Study ID Numbers: KN026-205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No