Status:
TERMINATED
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
Lead Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions:
HER2-positive Metastatic Breast Cancer
Eligibility:
All Genders
18-75 years
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 ...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04778982
Start Date
May 25 2022
End Date
March 15 2023
Last Update
July 17 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China