Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07581314 | Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) | PHASE1 | NOT YET_RECRUITING | 76 | — | — | May 1, 2026 | Nov 1, 2027 | May 12, 2026 | - | — |
| Arm | Type | Description |
|---|---|---|
| Phase I Dose Escalation | EXPERIMENTAL | 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 | 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. |
| Name | Type | Description |
|---|---|---|
| Zn-Telomir | DRUG | Zn-Telomir are oral capsules that work by regulating essential metals like iron and copper, extending and protecting telomere caps, and defending against oxidative stress, DNA damage, chronic inflammation, and mitochondrial dysfunction. |
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 systemi...