ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

Last updated: August 27, 2024
Sponsor: Fudan University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Cancer

Breast Cancer

Treatment

ARX788

Clinical Study ID

NCT06578286
ACE-Breast-10
  • Ages 18-75
  • All Genders

Study Summary

A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 to 75 years old (including upper and lower limits), male or female;

  2. Unresectable locally advanced, recurrent or metastatic BC;

  3. Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);

  4. Received T-DXd treatment in the advanced stage;

  5. Adequate bone marrow, liver, kidney and coagulation function;

  6. Voluntarily sign the informed consent, have good compliance and are willing tocomply with the follow-up visit.

Exclusion

Exclusion Criteria:

  1. With meningeal metastases or disseminated brain metastases or active brainmetastases;

  2. Has interstitial lung disease requiring steroid therapy, a history of drug-inducedinterstitial lung disease, a history of radiation pneumonitis, or any evidenceindicating clinically active interstitial lung disease;

  3. Has any eye disease that require medical intervention such as keratitis, cornealdiseases or active eye infection;

  4. Has cardiac insufficiency;

  5. Has received any systemic anti-tumor therapy (with the exception of endocrinetherapy, with an interval of at least 7 days) within 28 days (or at least 5half-lives) before the first use of the investigational product;

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: ARX788
Phase: 2
Study Start date:
September 30, 2024
Estimated Completion Date:
September 30, 2030