Clinical trial NCT04778982: Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HER2-positive Metastatic Breast Cancer
Keywords: KN026
palbociclib
HER2-positive MBC
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosing locally advanced unresectable or metastatic HER2-positive

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.

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

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: up to 24 weeks
measure: Objective response rate (ORR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: through study completion, an average of 1 year
measure: Progression free survival (PFS) rates
timeFrame: 6 months and 12 months
measure: Overall survival (OS)
timeFrame: 6 months and 12 months
measure: Clinical benefit rate (CBR)
timeFrame: CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: