Triple-Negative Breast Cancer (TNBC)Phase 1/2NCT07581314
Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)
A Phase 1/2 study testing Zn-Telomir in people with Triple-Negative Breast Cancer (TNBC) and Advanced Triple-Negative Breast Cancer, run by Telomir Pharmaceuticals, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC), Advanced Triple-Negative Breast Cancer, Metastatic Triple-negative Breast Cancer
- What is being tested?
- Zn-Telomir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)
- Locally advanced unresectable or metastatic disease
- Must have completed prior anticancer therapy discontinued for a least 28 days
- Disease progression after prior systemic therapy for advanced/metastatic TNBC
- At least one measurable lesion (tumor)
- Age ≥18 years
Show all 9Show fewer
- Life expectancy ≥12 weeks
- Agreement to use highly effective contraception during study and for 3 months after treatment
- Ability to understand and sign informed consent
Who cannot join
- HER2-positive or hormone receptor-positive breast cancer
- Active leptomeningeal disease
- Uncontrolled, symptomatic CNS metastases
- Concurrent participation in another interventional clinical trial
- Clinically significant cardiovascular disease
- Uncontrolled infection requiring systemic therapy
Show all 11Show fewer
- Known Human Immunodeficiency Virus (HIV) with detectable viral load >400 copies/mL
- Active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV)
- Significant Gastrointestinal (GI) disorders
- Active bleeding disorders or coagulopathy
- Pregnancy or breastfeeding
About this study
Official title: 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)
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
- Triple-Negative Breast Cancer (TNBC), Advanced Triple-Negative Breast Cancer, Metastatic Triple-negative Breast Cancer
- Being tested
- Zn-Telomir
- Keywords
- Triple-Negative Breast Cancer, Zn-Telomir, TNBC, Metastatic Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zn-TelomirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zn-Telomir |
| 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. Receives: Drug: Zn-Telomir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of Serious Adverse Events (SAEs) and incidence and severity of Treatment-Emergent AEs (TEAEs)
Measured: From first dose up to approximately 6 months
Phase II: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: From first recommended dose up to 4 months.
Secondary outcomes (2)
Phase I: Maximum Plasma concentration (Cmax)
Measured: From first dose up to 6 months.
Phase I: Half-life (T1/2)
Measured: first dose up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telomir Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581314
- Sponsor's protocol ID
- TELO-001
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07581314
- Acronym / sponsor ID
- TELO-001
- Conditions
- Triple-Negative Breast Cancer (TNBC), Advanced Triple-Negative Breast Cancer, Metastatic Triple-negative Breast Cancer
- Keywords
- Triple-Negative Breast Cancer, Zn-Telomir, TNBC, Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Telomir Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Escalation | Experimental | Drug: Zn-TelomirParticipants 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-TelomirParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)
- Locally advanced unresectable or metastatic disease
- Must have completed prior anticancer therapy discontinued for a least 28 days
- Disease progression after prior systemic therapy for advanced/metastatic TNBC
- At least one measurable lesion (tumor)
Key exclusion criteria (11 listed)
- HER2-positive or hormone receptor-positive breast cancer
- Active leptomeningeal disease
- Uncontrolled, symptomatic CNS metastases
- Concurrent participation in another interventional clinical trial
- Clinically significant cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zn-TelomirZn-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. | Drug | Phase I Dose Escalation, Phase II Dose Expansion |
Primary outcome
Phase I: Incidence of Serious Adverse Events (SAEs) and incidence and severity of Treatment-Emergent AEs (TEAEs)
Time frame: From first dose up to approximately 6 months
Phase II: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: From first recommended dose up to 4 months.
2 secondary outcomes
Phase I: Maximum Plasma concentration (Cmax)
Time frame: From first dose up to 6 months.
Phase I: Half-life (T1/2)
Time frame: first dose up to approximately 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Related trials for Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zn-Telomir in people with Triple-Negative Breast Cancer (TNBC) and Advanced Triple-Negative Breast Cancer, run by Telomir Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence of Serious Adverse Events (SAEs) and incidence and severity of Treatment-Emergent AEs (TEAEs) (time frame: From first dose up to approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.