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.
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
HER2-positive or hormone receptor-positive breast cancer
Active leptomeningeal disease
Uncontrolled, symptomatic CNS metastases
Concurrent participation in another interventional clinical trial