To hear about similar clinical trials, please enter your email below
Trial Title:
ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
NCT ID:
NCT06578286
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ARX788
Description:
ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle
Arm group label:
ARX788
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.
Criteria for eligibility:
Criteria:
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 to
comply with the follow-up visit.
Exclusion Criteria:
1. With meningeal metastases or disseminated brain metastases or active brain
metastases;
2. 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;
3. Has any eye disease that require medical intervention such as keratitis, corneal
diseases or active eye infection;
4. Has cardiac insufficiency;
5. 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 30, 2024
Completion date:
September 30, 2030
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06578286
