Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Triple-Negative Breast Cancer | Triple-Negative Breast Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | CURATED_BROADER | 0.78 |
| Triple-Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zn-Telomir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I Dose Escalation
- description
- 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.
- interventionNames
- Drug: Zn-Telomir
- type
- EXPERIMENTAL
- label
- Phase II Dose Expansion
- description
- 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.
- interventionNames
- Drug: Zn-Telomir
Primary outcomes (2)
- measure
- Phase I: Incidence of Serious Adverse Events (SAEs) and incidence and severity of Treatment-Emergent AEs (TEAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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