Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer

Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer

This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Concurrent chemotherapy and KN026; Drug: KN026 monotherapy; Drug: KN026 combination

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.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Harbin Medical University Cancer Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female subject >= 18 years
• Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer
• ECOG score 0 or 1
• Life expectancy >3 months
• According to the definition of RECIST1.1, the patient has at least one measurable lesion
• Adequate organ function prior to start treatment with KN026
• Able to understand, voluntarily participate and willing to sign the ICF

Exclusion Criteria:

• Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
• Accepted radiotherapy within 4 weeks before enrollment
• Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
• Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
• History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
• History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
• Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concurrent chemotherapy and KN026; KN026 combined with docetaxol	Drug: Concurrent chemotherapy and KN026; 30 mg/kg Q3W KN026 75 mg/m2 docetaxol; Other Names: docetaxol
Experimental: KN026 monotherapy	Drug: KN026 monotherapy; 30 mg/kg Q3W KN026; Other Names: KN026
Experimental: A combination treatment of KN026 and KN046; KN026 combined with KN046	Drug: KN026 combination; 30 mg/kg Q3W KN026 5 mg/kg Q3W KN046; Other Names: KN046

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment	Throughout the duration of the study; up to 2 years
Duration of response (DOR)	Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS) rates	Progression free survival (PFS) rates	6 months and 12 months
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest	AEs, SAEs	Throughout the duration of the study
Overall survival (OS) rates	Overall survival (OS) rates	6 months and 12 months
durable benefit rate (DBR)	durable benefit rate (DBR)	DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Investigators: Principal Investigator: Qingyuan Zhang, Professor, The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): May 27, 2021
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: KN026-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No