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Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)
Sponsor: Telomir Pharmaceuticals, Inc.
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2026-10
Completion Date
2027-11
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
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.