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Trial record 3 of 3 for:    A-166
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HER2-positive Breast Cancer Project Initiated by Investigators

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: NCT05346328
Recruitment Status : Not yet recruiting
First Posted : April 26, 2022
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University

Study Description
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Brief Summary:
This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease control rate (DCR), clinical benefit rate (CBR), duration of response (DOR) and Time to Response (TTR). Injection of A166 for HER2-positive patients with refractory unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug therapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Injection of A166 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study adopts an open research design and selects patients with refractory HER2-positive unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug treatment. The patients who met the enrollment conditions were treated with injection of A166.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-clinical Trial Phase Ⅱ, Injection of A166 for HER2-positive Patients With Refractory Unresectable Locally Advanced or Metastatic Breast Cancer；KL166-IIS-001
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Group Assignment
This study adopts an open research design and selects patients with refractory HER2-positive unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug treatment. The patients who met the enrollment conditions were treated with injection of A166.
 Drug: Injection of A166
4.8 mg/kg for each 21 (±3) -day cycle


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate（ORR） [ Time Frame: 2 years ]
    ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1.


Secondary Outcome Measures :
  1. Progression-free survival(PFS) [ Time Frame: 2 years ]
    PFS is defined as the time between date of first dose of study therapy and date of progression or death according RECIST 1.1.

  2. Disease control rate(DCR) [ Time Frame: 2 years ]
    DCR is defined as cases where objective remission(assessed as complete remission or partial remission according RECIST 1.1 standard) or stable disease during the study.

  3. Clinical benefit rate(CBR) [ Time Frame: 2 years ]
    CBR is defined as the proportion of patients with a complete or partial response or with stable disease according RECIST 1.1

  4. Duration of rate(DOR) [ Time Frame: 2 years ]
    DOR is defined the time between the first tumor evaluation for CR or PR and the first evaluation for PD(Progressive Disease) or death from any cause according RECIST 1.1.

  5. Time to response(TTR) [ Time Frame: 2 years ]
    TTP is defined as the time between randomization and objective tumor progression according RECIST 1.1; TTP does not include death

  6. Overall survival(OS) [ Time Frame: 2 years ]
    Overall survival(OS) is defined as the time from first dose of study therapy to the date of death(any case).Subjects who are alive censored at the last known time that the subject was alive.


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

Inclusion Criteria:

  • 1. Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form; 2. Breast cancer patients by histopathology and/or cytology documented, including:

    a) Participants with unresectable locally advanced or metastatic breast cancer; b) Evaluated or tested as HER2-positive expression. The definition of HER2 positive in this study: immunohistochemistry (IHC) was 2+ and confirmed by fluorescence in situ hybridization (FISH), or IHC was 3+; 3. Have received at least 3 targeted therapies for locally advanced or metastatic disease, including:

    1. Disease progression after receiving at least 1 trastuzumab-containing (including a biosimilar of trastuzumab on the market)-based treatment;
    2. After receiving at least one anti-HER2 tyrosine kinase inhibitor (lapatinib or pyrrotinib)-based treatment plan, the disease progresses or cannot tolerate toxic and side effects;

    3. The disease progresses or cannot tolerate toxic and side effects after receiving treatment with antibody-conjugated drugs targeting HER2 (such as T-DM1 or other ADCs); Note: Adjuvant therapy and anti-HER2 therapy used in the neoadjuvant treatment stage before radical treatment are not counted, but recurrence or metastasis occurs during the last anti-HER2 medication period or within one year after the end, it can be regarded as a plan.

      4. Have previously received taxanes to treat breast cancer;

      Exclusion Criteria:

  • 1. Serious or uncontrollable heart diseases that require treatment, including:

    1. Congestive heart failure graded 3 or 4 by the New York College of Cardiology (NYHA);
    2. Unstable angina pectoris that cannot be controlled by drugs;
    3. Myocardial infarction occurred within 6 months before the first administration of the study treatment;
    4. Severe arrhythmia requiring medical treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia); 2. Baseline measurement, QTc interval, male> 450 msec, female> 470 msec; 3. Clinically active interstitial lung disease; 4. Patients with primary central nervous system (CNS) malignant tumors or CNS metastases that have failed local treatment; for asymptomatic brain metastases, or with stable clinical symptoms and no need for steroids and other brain metastases within 4 weeks before the first administration of the trial drug Treated patients can be included in the group; 5. Those who are known to have a history of hypersensitivity to other monoclonal antibodies or allergic to A166 and its components for injection; 6. Those who have permanently discontinued trastuzumab due to any toxicity;
Contacts and Locations
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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): NCT05346328


Contacts
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Contact: Xichun Hu, Doctor 18017312175 xchu2009@hotmail.com
Contact: Jian Zhang, Master 13918273761 syner2000@163.com

Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xichun Hu, Doctor Chief Physician
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Xichun Hu, Chief Physician, Fudan University
ClinicalTrials.gov Identifier: NCT05346328    
Other Study ID Numbers: KL166-IIS-001
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xichun Hu, Fudan University:
HER2-positive Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases