Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)
2026年5月6日 更新者：Telomir Pharmaceuticals, Inc.
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)
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.
研究概览
研究类型
介入性
注册 (估计的)
76
阶段
- 阶段2
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Phase I Dose Escalation
Participants receive oral Zn-Telomir once daily on Days 1-14 of each 28-day cycle at assigned cohort dose levels of 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 400 mg.
Number of cycles will vary based on dose level and tolerability.
|
Zn-Telomir are oral capsules that work by regulating essential metals like iron and copper, extending and protecting telomere caps, and defending against oxidative stress, DNA damage, chronic inflammation, and mitochondrial dysfunction.
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实验性的：Phase II Dose Expansion
Participants receive oral Zn-Telomir at the recommended Phase II dose once daily on Days 1-14 of each 28-day cycle for up to 4 cycles, if tolerated.
|
Zn-Telomir are oral capsules that work by regulating essential metals like iron and copper, extending and protecting telomere caps, and defending against oxidative stress, DNA damage, chronic inflammation, and mitochondrial dysfunction.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Phase I: Incidence of Serious Adverse Events (SAEs) and incidence and severity of Treatment-Emergent AEs (TEAEs)
大体时间：From first dose up to approximately 6 months
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From first dose up to approximately 6 months
|
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Phase II: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
大体时间：From first recommended dose up to 4 months.
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From first recommended dose up to 4 months.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Phase I: Maximum Plasma concentration (Cmax)
大体时间：From first dose up to 6 months.
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From first dose up to 6 months.
|
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Phase I: Half-life (T1/2)
大体时间：first dose up to approximately 6 months
|
first dose up to approximately 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月1日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年11月1日
研究注册日期
首次提交
2026年4月29日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月6日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Zn-Telomir的临床试验
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