ARX788 in HER2-positive metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm phase 2 trial evaluating ARX788 given intravenously every 6 weeks in patients with HER2-positive metastatic breast cancer. Eligible participants have up to two prior lines of chemotherapy for metastatic disease and measurable lesions. The study will monitor safety and how well the cancer responds to treatment using standard imaging criteria. Treatment continues with regular follow-up visits to assess effects and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Has known history to be allergic to any active ingredient or excipient of ARX788;
* With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
* Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
* 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;
* Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;
* 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;
* 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 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.

Where it's running

• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Min Yan
• Email: ym200678@126.com
• Phone: +86 15713857388

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.