Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04521179
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : December 9, 2020
Sponsor:
Collaborator:
Peking University
Information provided by (Responsible Party):
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is an open-label, phase II，multi-center study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors.

Condition or disease Intervention/treatment Phase
HER2-positive Solid Tumors Drug: KN026 combination Phase 2

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.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The study composes of two stages. The first stage plans to enroll HER2-positive solid tumors. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W at the first stage.A SMC meeting will decide whether to proceed to the nest stage.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With KN046 in Patients With Locally Advanced Unresectable or Metastatic HER2-positive Solid Tumors
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: KN026 combined with KN046
KN026 combination therapy
 Drug: KN026 combination
30 mg/kg Q3W KN026+ 5 mg/kg Q3W KN046
Other Name: IO therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Objective response rate (ORR ) [ Time Frame: Throughout the duration of the study; up to 2 years ]
    Objective response rate as assessed by the investigator according to RECIST 1.1 criteria

  2. Duration of response (DOR) [ Time Frame: Throughout the duration of the study; up to 2 years ]
    Duration of response (DOR) as assessed by the investigator according to RECIST 1.1 criteria


Secondary Outcome Measures :
  1. Progression free survival (PFS) rates [ Time Frame: 6 months and 12 months ]
    Progression free survival (PFS) rates

  2. Clinical benefit rate (CBR) [ Time Frame: CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks ]
    Clinical benefit rate

  3. Overall survival (OS) [ Time Frame: 6 months and 12 months ]
    Overall survival (OS) rates


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject >= 18 years;
  • Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive solid tumors;
  • ECOG score 0 or 1;
  • Life expectancy >3 months;
  • Baseline measurable disease according to RECIST 1.1 as determined by the local site investigator/radiology assessment;
  • Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA;
  • Able to understand, voluntarily participate and willing to sign the ICF.

Exclusion Criteria:

  • Untreated active brain metastasis or leptomeningeal metastasis;
  • History of Left ventricular ejection fraction (LVEF) decline to < 45% or absolute decrease for > 15% during the treatment course from prior HER2-targeted therapy;
  • Has received other anti-tumor treatment or an investigational drug within 28 days prior to the first trial treatment;
  • Major surgery for any reason within 28 days ;
  • Prior allo-HSCT or solid organ transplant;
  • Pregnant or nursing females;or intend pregnancy within this study period or within 6 months after the end of this study;
  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521179


Contacts
Layout table for location contacts
Contact: Jifang Gong, professor 0086-10-88196391 goodjf@163.com

Locations
Layout table for location information
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Lin Shen, MD,PhD    010-88196561    linshenpku@163.com   
Principal Investigator: Lin Shen, MD,PhD         
Sponsors and Collaborators
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Peking University
Investigators
Layout table for investigator information
Principal Investigator: Lin Shen, professor Beijing Cancer Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier: NCT04521179    
Other Study ID Numbers: KN026-203
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Alphamab Biopharmaceuticals Co., Ltd:
KN026 and KN046
HER2-Positive Solid Tumor
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms