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.

NCT Number	NCT07581314
Lead Sponsor	Telomir Pharmaceuticals, Inc.
Conditions	Triple-Negative Breast Cancer (TNBC), Advanced Triple-Negative Breast Cancer, Metastatic Triple-negative Breast Cancer
Enrollment	76 participants
Start Date	2026-10
Primary Completion	2027-05 (estimated)
Study Completion	2027-11 (estimated)
Updated on ClinicalTrials.gov	2026-06-23