ARX788 in HER2-positive Metastatic Breast Cancer Patients

Henan Cancer Hospital

Status and phase

Not yet enrolling

Phase 2

Conditions

HER2-positive, Metastatic Breast Cancer

Treatments

Drug: ARX788

Study type

Interventional

Funder types

Other

Identifiers

NCT06663748

ACE-Breast-09

Details and patient eligibility

About

A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.

Full description

A single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients. The ARX788 will be administered every 6 weeks (Q6W) intravenous (IV) infusion.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.