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New pill takes on tough breast cancer in first human trial

NCT ID NCT07581314

Disease control Sponsor: Telomir Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests an oral drug called Zn-Telomir in 76 adults with advanced or metastatic triple-negative breast cancer that has worsened after prior treatments. The study has two parts: first, finding a safe dose, and second, checking if the drug shrinks tumors. It is the first time this drug is being tested in humans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zn-Telomir (oral capsules that regulate metals and protect telomeres)
What this could lead to
If it works, this could point toward a new oral treatment option for advanced triple-negative breast cancer, a hard-to-treat cancer.
What could go wrong
This is a very early first-in-human trial with only 76 participants, so safety and effectiveness are not yet known. Many early cancer drugs fail to show benefit in larger studies.
Why investors are watching

Telomir Pharmaceuticals is testing its drug Zn-Telomir in people for the first time, as a daily pill for advanced triple-negative breast cancer. This small company has no approved products, so this early-stage trial is the main test of whether its approach works and is safe. A clear result matters because it will shape the company's value and future plans.

If it works: If the drug shows acceptable safety and signs of shrinking tumors, Telomir could advance to a larger study and build credibility with researchers and partners. A positive readout could also support the company's case for continued funding.

If it fails: Most first-in-human cancer drugs fail to show enough benefit or prove too toxic, and this trial could also face delays in enrollment or dosing. A negative or unclear result would likely hurt the company's prospects, since it has few other assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced triple negative breast cancer Metastatic triple-negative breast cancer Triple negative breast cancer (TNBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.