Advanced Triple-Negative Breast Cancer, Metastatic Triple-negative Breast Cancer, Triple-Negative Breast Cancer (TNBC)
Conditions
Keywords
Triple-Negative Breast Cancer, Zn-Telomir, TNBC, Metastatic Breast Cancer
Brief summary
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.
Interventions
DRUGZn-Telomir
Zn-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.
Sponsors
Telomir Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study has 2 sequential parts: Phase I modified 3+3 dose escalation followed by Phase II Simon two-stage dose expansion at the recommended phase II dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed