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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARX788 | Experimental | ARX788,1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARX788 | Drug | ARX788,1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate (ORR) | The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1. | Until progression, assessed up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1. | Baseline through end of study, assessed up to 24 months] |
| Duration of relief (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhang, MD,PhD | Contact | +8664175590 | 85000 | syner2000@163.com |
| Yanchun Meng, MD | Contact | +8664175590 | 85000 | ycmnankai@126.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000710874 | ARX788 |
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Time from the date of first documented response until the date of documented progression or death in the absence of disease progression
| Until progression, assessed up to approximately 24 months |
| Progression-free survival (PFS) | Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause. | Until progression or death, assessed up to approximately 36 months] |
| Overall survival (OS) | Time to death due to any cause | Until death, assessed up to approximately 50 months |
| The number of subjects experiencing adverse event TEAEs | Occurrence of AEs according to CTCAE v5.0 | Up to follow-up period, approximately 50 months |
| D017437 |
| Skin and Connective Tissue Diseases |