KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

July 25, 2019 updated by: JZhao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

59

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Written informed consent
  • Female subjects with age 18 to 70 (inclusive) years at the time of consent
  • LVEF ≥50% at baseline
  • ECOG performance status of 0-1
  • Have not received 1L treatment for recurrent or metastatic breast cancer
  • Adequate organ function

Exclusion Criteria:

  • History of exposure to the cumulative doses of doxorubicin > 400 mg / m2 or equivalent
  • History of autoimmune diseases
  • Active brain metastasis
  • Concurrent diseases that compromise patient's safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: KN035 in combination with trastuzumab and docetaxel
Biological: KN035
KN035 5 mg/kg s.c. Q3W
Biological: Trastuzumab
8 mg/kg IV loading followed by 6 mg/kg Q3W IV
Drug: Docetaxel
100 mg/m2 Q3W IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response
Time Frame: 12 months

To estimate the overall response rate (CR + PR) of KN035 in combination with trastuzumab and docetaxel in patients with recurrent or metastatic HER2-positive breast cancer.

• Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 12 months
To characterize the toxicity of KN035 in combination with trastuzumab and docetaxel as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE)
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: 12 months
To estimate the disease control rate (CR + PR + SD) of KN046 in combination with trastuzumab and docetaxel. Disease control rate will include complete response (CR], partial response (PR), and stable disease (SD), as per RECIST v1.1 criteria
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (ACTUAL)

July 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KN035-TH-HER2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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