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

NCT04778982 | Terminated FDA Drug

• 1 other identifier: KN026-205
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Metastatic Breast Cancer

Keywords

KN026; palbociclib; HER2-positive MBC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Duration of response (DOR)

  through study completion, an average of 1 year

• Progression free survival (PFS) rates

  6 months and 12 months

• Overall survival (OS)

  6 months and 12 months

• Clinical benefit rate (CBR)

  CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks

Study Arms (2)

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

Interventions

KN026 combined with Palbociclib and Fulvestrant DRUG

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

Also known as: combination

parallel-group expansion Phase

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diagnosing locally advanced unresectable or metastatic HER2-positive

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA and single cell sequencing analysis may be performed using plasma samples collected from subjects at baseline and upon disease progression.

MeSH Terms

Interventions

palbociclib; Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: May 25, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

CN (1)