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Trial Title:
ARX788 in HER2-positive Metastatic Breast Cancer Patients
NCT ID:
NCT06663748
Condition:
HER2-positive, Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
ARX788
HER2-positive breast cancer
Q6W
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ARX788
Description:
2.2 mg/kg IV infusion on Day 1 of each 42-day treatment cycle.
Arm group label:
ARX788
Summary:
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer
patients.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 20, 2024
Completion date:
November 20, 2029
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06663748
