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

NCT07581314 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TELO-001
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Triple-Negative Breast Cancer (TNBC); Advanced Triple-Negative Breast Cancer; Metastatic Triple-negative Breast Cancer

Keywords

Triple-Negative Breast Cancer; Zn-Telomir; TNBC; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

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

  From first dose up to approximately 6 months

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

  From first recommended dose up to 4 months.

Secondary Outcomes (2)

• Phase I: Maximum Plasma concentration (Cmax)

  From first dose up to 6 months.

• Phase I: Half-life (T1/2)

  first dose up to approximately 6 months

Study Arms (2)

Phase I Dose Escalation

EXPERIMENTAL

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

Phase II Dose Expansion

EXPERIMENTAL

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

Interventions

Zn-Telomir DRUG

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.

Phase I Dose Escalation; Phase II Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Telomir Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study has 2 sequential parts: Phase I modified 3+3 dose escalation followed by Phase II Simon two-stage dose expansion at the recommended phase II dose.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05