ARX788 in HER2-positive Metastatic Breast Cancer Patients

Официальное название

Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients with HER2-positive Advanced Breast Cancer

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат ARX788
  2.2 mg/kg IV infusion on Day 1 of each 42-day treatment cycle.

Первичные конечные точки

• Objective remission rate (ORR) [Срок оценки: up to 2 years]

Вторичные конечные точки (12)

• Disease control rate (DCR) [Срок оценки: up to 2 years]
• Duration of relief (DOR) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: up to 2 years]
• Pharmacokinetic parameter: Maximum concentration (Cmax) [Срок оценки: At the end of Cycle 1 (each cycle is 42 days)]
• Pharmacokinetic parameter: Time to Cmax (tmax) [Срок оценки: At the end of Cycle 1 (each cycle is 42 days)]
• Pharmacokinetic parameter: Terminal half-life (t1/2) [Срок оценки: 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)] [Срок оценки: 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)] [Срок оценки: At the end of Cycle 1 (each cycle is 42 days)]
• Pharmacokinetic parameter: Terminal rate constant (λz) [Срок оценки: At the end of Cycle 1 (each cycle is 42 days)]
• Pharmacokinetic parameter: Systemic clearance (CL) [Срок оценки: At the end of Cycle 1 (each cycle is 42 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06663748 · ACE-Breast-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗