NCT07581314Not yet recruitingPhase 1/2
Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)
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)
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 29 Apr 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Telomir Pharmaceuticals, Inc.
- NCT number
- NCT07581314
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 76
- From 1 Oct 2026 to the primary completion date, 31 May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another interventional clinical trial
Other illness
- HER2-positive or hormone receptor-positive breast cancer
- Active leptomeningeal disease
- 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
Other
- Uncontrolled, symptomatic CNS metastases
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.