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

NCT ID: NCT04778982

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2023-03-15

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.

Conditions

HER2-positive Metastatic Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

dose-escalation Phase

KN026 20 mg/kg + palbociclib125 mg/day+Fulvestrant 500 mg (Patients with HR+/HER2-positive MBC )

No interventions assigned to this group

parallel-group expansion Phase

KN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC )

KN026 combined with Palbociclib and Fulvestrant

Intervention Type: DRUG

HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg

Interventions

KN026 combined with Palbociclib and Fulvestrant

HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg

Intervention Type: DRUG

Other Intervention Names

combination

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

Other Identifiers

KN026-205

Identifier Type: -

Identifier Source: org_study_id