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Not yet recruiting NCT07581314

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

Phase I / Phase II Interventional Triple-Negative Breast Cancer (TNBC) Advanced Triple-Negative Breast Cancer Metastatic Triple-negative Breast Cancer

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: Zn-Telomir.
Who it may be relevant to
Registry conditions: Triple-Negative Breast Cancer (TNBC), Advanced Triple-Negative Breast Cancer, Metastatic Triple-negative Breast Cancer. Basic parameters: from 18 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

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)

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07581314 · TELO-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗