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

May 6, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Zn-Telomir
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.
Experimental: 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.
Drug: Zn-Telomir
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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.
From first recommended dose up to 4 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase I: Maximum Plasma concentration (Cmax)
Time Frame: From first dose up to 6 months.
From first dose up to 6 months.
Phase I: Half-life (T1/2)
Time Frame: first dose up to approximately 6 months
first dose up to approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telomir Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TELO-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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