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

NCT05291910 | Unknown Phase 4

• 1 other identifier: SPT-2021-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  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 Outcomes (3)

• Objective response rate (ORR)

  Assessed up to approximately 24 months

• Clinical benefit rate (CBR)

  Assessed up to approximately 24 months

• Safety assessment (AEs and SAEs)

  From the time of inform consent form signature until 30 days after end of treatment

Study Arms (1)

Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel

EXPERIMENTAL

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: Inetetamab; Drug: Toripalimab; Drug: Albumin-Bound Paclitaxel

Interventions

Inetetamab DRUG

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

Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel

Toripalimab DRUG

240mg intravenously every 3 weeks

Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel

Albumin-Bound Paclitaxel DRUG

130mg/m2, IV , D1, D8, q3w

Inetetamab+ Toripalimab+ Albumin-Bound Paclitaxel

Eligibility Criteria

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

You may qualify if:

• Female patients aged \> 18 years.
• Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or ICH++ with fluorescence in situ hybridization results were positive).
• Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent or radiological evidence of metastatic disease.
• Patients with locally recurrent inoperable or metastatic HER2-positive breast cancer:
• patients with metastatic breast cancer at the time of initial diagnosis, meaning there was no previous history of breast cancer in the past; or
• patients with Locally recurrent or metastatic breast cancer, neoadjuvant/adjuvant anti-HER2 therapy has been completed for ≥6 months.
• HER2-positive recurrent or metastatic BC patients who have received at most one anti-HER2 therapy after diagnosis;.
• PD-L1-positive (cut-off ≥ 1% stained cells);
• Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria.
• ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up.
• Cardiopulmonary function is basically normal.
• Liver function is basically normal.
• Have sufficient baseline hematology parameters.
• 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.
• No history of serious heart, kidney and other important organs and endocrine disease.

You may not qualify if:

• Participated in other clinical trials within 4 weeks;
• Evidence of symptomatic central nervous system metastasis or pia mater disease.
• History of receiving CD137 agonists or checkpoint blockade therapy (including anti-CD40, anti-CTLA-4, anti-PD-1, anti-PD-L1 monoclonal antibody therapy).
• History of receiving paclitaxel for injection (Albumin Bound) in first-line chemotherapy for advanced disease.
• History of autoimmune disease Including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (IBD), etc.
• 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.
• History of acute or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV).
• History of primary or acquired immunodeficiency (including HIV-positive).
• History of hypersensitivity to the study medication
• Pregnancy or lactation.
• 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.
• 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).
• Participants who were judged by the investigator to be unsuitable for this study .

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy Of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

toripalimab; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Binghe Xu, MD

  Director of Breast Cancer Section

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu, MD

CONTACT

010-67781331; xubinghe@medail.com.cn

Ying Fan, MD

CONTACT

010-67781331; pearloffan@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Breast Cancer Section

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: March 12, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

CN (1)