Not yet recruiting NCT06663748
ARX788 in HER2-positive Metastatic Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARX788.
- Who it may be relevant to
- Registry conditions: HER2-positive, Metastatic Breast Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients with HER2-positive Advanced Breast Cancer
Overview
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.
Interventions
- Drug ARX788
2.2 mg/kg IV infusion on Day 1 of each 42-day treatment cycle.
Primary outcome measures
- Objective remission rate (ORR) [Time frame: up to 2 years]
Secondary outcome measures (12)
- Disease control rate (DCR) [Time frame: up to 2 years]
- Duration of relief (DOR) [Time frame: From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.]
- Progression-free survival (PFS) [Time frame: From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.]
- Overall survival (OS) [Time frame: From the date of first dose of study drug to any-cause death, assessed up to 5 years]
- The number of subjects experiencing adverse event TEAEs [Time frame: up to 2 years]
- Pharmacokinetic parameter: Maximum concentration (Cmax) [Time frame: At the end of Cycle 1 (each cycle is 42 days)]
- Pharmacokinetic parameter: Time to Cmax (tmax) [Time frame: At the end of Cycle 1 (each cycle is 42 days)]
- Pharmacokinetic parameter: Terminal half-life (t1/2) [Time frame: At the end of Cycle 1 (each cycle is 42 days)]
- Pharmacokinetic parameter: Area under the concentration-time curve from zero extrapolated to infinity [AUC(0-inf)] [Time frame: At the end of Cycle 1 (each cycle is 42 days)]
- Pharmacokinetic parameter: Area under the concentration-time curve from zero to the last quantifiable concentration [AUC(0-last)] [Time frame: At the end of Cycle 1 (each cycle is 42 days)]
- Pharmacokinetic parameter: Terminal rate constant (λz) [Time frame: At the end of Cycle 1 (each cycle is 42 days)]
- Pharmacokinetic parameter: Systemic clearance (CL) [Time frame: At the end of Cycle 1 (each cycle is 42 days)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06663748 · ACE-Breast-09