Breast Cancer
Conditions
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) infusion.
Interventions
DRUGARX788
ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective remission rate (ORR) | Until progression, assessed up to approximately 24 months | The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | Baseline through end of study, assessed up to 24 months] | The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1. |
| Duration of relief (DOR) | Until progression, assessed up to approximately 24 months | Time from the date of first documented response until the date of documented progression or death in the absence of disease progression |
| Progression-free survival (PFS) | Until progression or death, assessed up to approximately 36 months] | Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause. |
| Overall survival (OS) | Until death, assessed up to approximately 50 months | Time to death due to any cause |
| The number of subjects experiencing adverse event TEAEs | Up to follow-up period, approximately 50 months | Occurrence of AEs according to CTCAE v5.0 |
Contacts
Primary ContactJian Zhang, MD,PhD
Backup ContactYanchun Meng, MD
Outcome results
None listed