Status:
NOT_YET_RECRUITING
ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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) in...
Eligibility Criteria
Inclusion
- 18 to 75 years old (including upper and lower limits), male or female;
- Unresectable locally advanced, recurrent or metastatic BC;
- Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
- Received T-DXd treatment in the advanced stage;
- Adequate bone marrow, liver, kidney and coagulation function;
- Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.
Exclusion
- With meningeal metastases or disseminated brain metastases or active brain metastases;
- Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
- Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
- Has cardiac insufficiency;
- Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06578286
Start Date
September 30 2024
End Date
September 30 2030
Last Update
August 29 2024
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