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Zn-Telomir

Phase 1

Triple-Negative Breast Cancer (TNBC) | Small molecule | Oncology |Telomir Pharmaceuticals, Inc.|Last Updated: Jun 23, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical trial landscape

Zn-Telomir · 1 trial · 3 indications

Phase 1 1
NCT07581314Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)Triple-Negative Breast Cancer (TNBC)
NOT YET_RECRUITING76 Analytics
PHASE1NOT YET_RECRUITING
Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)Unlock trial analytics
Study Endpoints
Primary Endpoints
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
Phase II: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
From first recommended dose up to 4 months.
Secondary Endpoints
Phase I: Maximum Plasma concentration (Cmax)
From first dose up to 6 months.
Phase I: Half-life (T1/2)
first dose up to approximately 6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase I Dose EscalationEXPERIMENTALParticipants 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 ExpansionEXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
Zn-TelomirDRUGZn-Telomir is an oral small molecule that inhibits iron-dependent KDM enzymes, reduces tumor DNA methylation, and kills cancer cells in an iron-dependent manner - targeting epigenetic and metal homeostasis drivers of cancer cell survival.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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...

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Recent Changes (Last 90 Days)
MEDIUMJun 23, 2026NCT07581314startDate: changed
MEDIUMJun 23, 2026NCT07581314startDate: changed
LOWMay 26, 2026NCT07581314primaryCompletionDate: changed
LOWMay 24, 2026NCT07581314studyFirstPostDate: changed
LOWMay 21, 2026NCT07581314NEW_TRIAL: changed
LOWMay 21, 2026NCT07581314NEW_TRIAL: changed