Zn-Telomir

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

Ensayo de Telomir Pharmaceuticals, Inc. en Triple-Negative Breast Cancer (TNBC) · Advanced Triple-Negative Breast Cancer · Metastatic Triple-negative Breast Cancer (del registro, en inglés).

Fase: Fase 1/2
Estado: Aún sin reclutar
Participantes: 76
Fin del objetivo primario: may 2027

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en oct 2026.

Qué mide

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) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Ficha completa en ClinicalTrials.gov (NCT07581314), actualizada en jun 2026.