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

NCT04165993 | Unknown Phase 2

• 1 other identifier: KN026-201
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest

  Throughout the duration of the study

• Progression free survival (PFS) rates

  6 months and 12 months

• Overall survival (OS) rates

  6 months and 12 months

• durable benefit rate (DBR)

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

Study Arms (3)

Concurrent chemotherapy and KN026

EXPERIMENTAL

KN026 combined with docetaxol

Drug: Concurrent chemotherapy and KN026

KN026 monotherapy

EXPERIMENTAL

KN026 monotherapy

Drug: KN026 monotherapy

A combination treatment of KN026 and KN046

EXPERIMENTAL

KN026 combined with KN046

Drug: KN026 combination

Interventions

Concurrent chemotherapy and KN026 DRUG

30 mg/kg Q3W KN026 75 mg/m2 docetaxol

Also known as: docetaxol

Concurrent chemotherapy and KN026

KN026 monotherapy DRUG

30 mg/kg Q3W KN026

Also known as: KN026

KN026 monotherapy

KN026 combination DRUG

30 mg/kg Q3W KN026 5 mg/kg Q3W KN046

Also known as: KN046

A combination treatment of KN026 and KN046

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Qingyuan Zhang, Professor

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 18, 2019
• Study Start: December 31, 2019
• Primary Completion: May 27, 2021
• Study Completion: December 31, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)