Tests ARX788 in adults with HER2-positive metastatic breast cancer
Tests the drug ARX788, given every 6 weeks, in adults with advanced HER2-positive breast cancer.
Plain-language title generated from the registry record
Registry title: ARX788 in HER2-positive Metastatic Breast Cancer Patients
Key facts
- Where
- Zhengzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06663748, who can take part
Where in China
- Henan Cancer HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Henan Cancer Hospital
- Trial code
- NCT06663748
- Record updated
- 16 October 2026
- Original description
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.Read full original descriptionShow less
Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients With HER2-positive Advanced Breast Cancer
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.
Inclusion: 18 to 75 years old (including upper and lower limits), male or female; Unresectable locally advanced, recurrent or metastatic BC; Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC; Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+); Has at least one measurable target lesion as per RECIST1.1 criteria; Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment; Adequate bone marrow, liver, kidney and coagulation function; ECOG Performance Status Score of 0-1; 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, who need radiation, surgery or drug therapy; Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial; 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; Has known history to be allergic to any active ingredient or excipient of ARX788; 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; Uncontrolled hypertension; Has evidence of severe or uncontrollable systemic diseases; Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form; Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance; Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment; Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial; Is unwilling or unable to stop wearing corneal contact lens during the trial.