Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07581314

Oral Zn-Telomir 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Triple-Negative Breast Cancer (TNBC) Advanced Triple-Negative Breast Cancer Breast Diseases Breast Neoplasms Metastatic Triple-negative Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zn-Telomir

Drug

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.

Primary outcomes

  1. Phase I: Incidence of Serious Adverse Events (SAEs) and incidence and severity of Treatment-Emergent AEs (TEAEs)

    Time frame: From first dose up to approximately 6 months

  2. Phase II: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: From first recommended dose up to 4 months.

Secondary outcomes

  1. Phase I: Maximum Plasma concentration (Cmax)

    Time frame: From first dose up to 6 months.

  2. Phase I: Half-life (T1/2)

    Time frame: first dose up to approximately 6 months

Sponsors and collaborators

Lead sponsor

Telomir Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.