Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer

March 14, 2022 updated by: Binghe Xu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Study to Assess the Efficacy and Safety of Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer

This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included. The purpose of this study is to evaluate the efficacy and safety of Inetetamab combined with anti-PD-1 monoclonal antibody and albumin-bound paclitaxel for HER2+ Metastatic Breast Cancer.To explore a new concept of anti-HER2 monoclonal antibody combined with immunotherapy in the treatment of recurrent or metastatic breast cancer. The primary end point is progression free survival (PFS). The secondary end points are objective response rate (ORR), Clinical Benefit Rate (CBR) and safety assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients aged > 18 years.
  2. Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or ICH++ with fluorescence in situ hybridization results were positive).
  3. Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent or radiological evidence of metastatic disease.

  4. Patients with locally recurrent inoperable or metastatic HER2-positive breast cancer:

    1. patients with metastatic breast cancer at the time of initial diagnosis, meaning there was no previous history of breast cancer in the past; or
    2. patients with Locally recurrent or metastatic breast cancer, neoadjuvant/adjuvant anti-HER2 therapy has been completed for ≥6 months.
  5. HER2-positive recurrent or metastatic BC patients who have received at most one anti-HER2 therapy after diagnosis;.
  6. PD-L1-positive (cut-off ≥ 1% stained cells);
  7. Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria.
  8. ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up.
  9. Cardiopulmonary function is basically normal.
  10. Liver function is basically normal.
  11. Have sufficient baseline hematology parameters.
  12. Coagulation Indicators: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal, unless drugs known to change INR and aPTT are used.
  13. No history of serious heart, kidney and other important organs and endocrine disease.
  14. Female patients of childbearing age have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures.
  15. The patients voluntarily signed an informed consent form.

Exclusion Criteria:

  1. Participated in other clinical trials within 4 weeks;
  2. Evidence of symptomatic central nervous system metastasis or pia mater disease.
  3. History of receiving CD137 agonists or checkpoint blockade therapy (including anti-CD40, anti-CTLA-4, anti-PD-1, anti-PD-L1 monoclonal antibody therapy).
  4. History of receiving paclitaxel for injection (Albumin Bound) in first-line chemotherapy for advanced disease.
  5. History of autoimmune disease Including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (IBD), etc.
  6. Immunosuppressive drugs required within 2 weeks before enrollment or during this study. The following conditions are excluded: 1) intranasal, inhalation, topical or local steroid injection (e.g., intra articular injection); 2) physiological doses of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent dose); 3) short term (≤ 7 days) use of steroids to prevent or treat non-autoimmune allergic diseases.
  7. History of acute or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV).
  8. History of primary or acquired immunodeficiency (including HIV-positive).
  9. History of hypersensitivity to the study medication
  10. Pregnancy or lactation.
  11. History of myocardial infarction within 6 months before enrollment, congestive heart failure (New York Heart Association [NYHA] Classes ≥ II), severe arrhythmia beyond drug control, or a decrease in LVEF to < 50% with previous trastuzumab neoadjuvant or adjuvant treatment.
  12. History of other malignant disease within 5 years (except cured of in-situ carcinoma of the cervix, basal cell carcinoma of the skin and squamous cell carcinoma).
  13. Participants who were judged by the investigator to be unsuitable for this study .

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel
Drug: Inetetamab Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks Drug: Toripalimab 240mg intravenously every 3 weeks Drug: Albumin-Bound Paclitaxel 130mg/m2, IV , D1, D8, q3w
Drug: Toripalimab
240mg intravenously every 3 weeks
Drug: Inetetamab
Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks
Drug: Albumin-Bound Paclitaxel
130mg/m2, IV , D1, D8, q3w

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Assessed up to approximately 24 months
PFS is defined as the time from the date of the first dose until first evidence of disease progression or death based on investigator assessment using RECIST 1.1 and irRECIST.
Assessed up to approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Assessed up to approximately 24 months
ORR is defined as the percentage of participants who have a complete response (CR) or partial response (PR) based on CT/MRI, investigator assessment using RECIST 1.1 and irRECIST.
Assessed up to approximately 24 months
Clinical benefit rate (CBR)
Time Frame: Assessed up to approximately 24 months
CBR is defined as the percentage of evaluable participants with best objective response of confirmed complete response or partial response per RECIST 1.1 and irRECIST, or prolonged stable disease (≥ 6 months).
Assessed up to approximately 24 months
Safety assessment (AEs and SAEs)
Time Frame: From the time of inform consent form signature until 30 days after end of treatment
Adverse Events (AEs) and Serious Adverse Events (SAEs)
From the time of inform consent form signature until 30 days after end of treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Binghe Xu, MD, Director of Breast Cancer Section

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPT-2021-002

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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