Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)

Официальное название

A First-in-Human (FIH), Phase I/II, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of Zn-Telomir Administered Orally as Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)

Обзор

This is a first-in-human, multicenter, open-label Phase I/II study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of oral Zn-Telomir monotherapy in adults with advanced or metastatic triple-negative breast cancer. Phase I uses a modified 3+3 dose-escalation design to determine safety, tolerability, maximum tolerated dose, and recommended Phase II dose. Phase II uses a Simon two-stage expansion design at the recommended Phase II dose to evaluate preliminary antitumor activity, including objective response rate per Response Evaluation Criteria in Solid Tumors.

Вмешательства

• Препарат Zn-Telomir
  Zn-Telomir is an oral small molecule that inhibits iron-dependent KDM enzymes, reduces tumor DNA methylation, and kills cancer cells in an iron-dependent manner - targeting epigenetic and metal homeostasis drivers of cancer cell survival.

Первичные конечные точки

• Phase I: Incidence of Serious Adverse Events (SAEs) and incidence and severity of Treatment-Emergent AEs (TEAEs) [Срок оценки: From first dose up to approximately 6 months]
• Phase II: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) [Срок оценки: From first recommended dose up to 4 months.]

Вторичные конечные точки (2)

• Phase I: Maximum Plasma concentration (Cmax) [Срок оценки: From first dose up to 6 months.]
• Phase I: Half-life (T1/2) [Срок оценки: first dose up to approximately 6 months]

Критерии участия

Критерии включения

• Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)
• Locally advanced unresectable or metastatic disease
• Must have completed prior anticancer therapy discontinued for a least 28 days
• Disease progression after prior systemic therapy for advanced/metastatic TNBC
• At least one measurable lesion (tumor)
• Age ≥18 years
• Life expectancy ≥12 weeks
• Agreement to use highly effective contraception during study and for 3 months after treatment
• Ability to understand and sign informed consent

Критерии исключения

• HER2-positive or hormone receptor-positive breast cancer
• Active leptomeningeal disease
• Uncontrolled, symptomatic CNS metastases
• Concurrent participation in another interventional clinical trial
• Clinically significant cardiovascular disease
• Uncontrolled infection requiring systemic therapy
• Known Human Immunodeficiency Virus (HIV) with detectable viral load >400 copies/mL
• Active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV)
• Significant Gastrointestinal (GI) disorders
• Active bleeding disorders or coagulopathy
• Pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07581314 · TELO-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗