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)
| Registry | NCT07581314 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; non randomized, sequential, masking: none, treatment |
| Enrollment | 76 (Estimated) |
| Sponsor | Telomir Pharmaceuticals, Inc. (Industry) |
| Conditions | Triple-Negative Breast Cancer (TNBC), Advanced Triple-Negative Breast Cancer, Metastatic Triple-negative Breast Cancer |
| Interventions | Zn-Telomir (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-05-12, last updated 2026-06-23 |
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All trials for Triple-Negative Breast Cancer (TNBC) All trials for Advanced Triple-Negative Breast Cancer All trials of Zn-Telomir
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Phase I Dose Escalation | Experimental | Drug: Zn-Telomir | Participants receive oral Zn-Telomir once daily on Days 1-14 of each 28-day cycle at assigned cohort dose levels of 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 400 mg. Number of cycles will vary based on dose level and tolerability. |
| Phase II Dose Expansion | Experimental | Drug: Zn-Telomir | Participants receive oral Zn-Telomir at the recommended Phase II dose once daily on Days 1-14 of each 28-day cycle for up to 4 cycles, if tolerated. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC) 2. Locally advanced unresectable or metastatic disease 3. Must have completed prior anticancer therapy discontinued for a least 28 days 4. Disease progression after prior systemic therapy for advanced/metastatic TNBC 5. At least one measurable lesion (tumor) 6. Age ≥18 years 7. Life expectancy ≥12 weeks 8. Agreement to use highly effective contraception during study and for 3 months after treatment 9. Ability to understand and sign informed consent Exclusion Criteria: 1. HER2-positive or hormone receptor-positive breast cancer 2. Active leptomeningeal disease 3. Uncontrolled, symptomatic CNS metastases 4. Concurrent participation in another interventional clinical trial 5. Clinically significant cardiovascular disease 6. Uncontrolled infection requiring systemic therapy 7. Known Human Immunodeficiency Virus (HIV) with detectable viral load >400 copies/mL 8. Active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV) 9. Significant Gastrointestinal (GI) disorders 10. Active bleeding disorders or coagulopathy 11. Pregnancy or breastfeeding