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Can a pill restore the Body's tumor suppressor to fight multiple cancers?

NCT ID NCT07752875

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial is testing an experimental oral drug, LG00313112, in people with advanced solid tumors that carry a specific genetic change called TP53 Y220C. The drug aims to restore the function of the p53 protein, which normally helps stop cancer growth. The study includes adults with various cancer types, such as ovarian, lung, colorectal, and breast cancer, whose disease has progressed despite standard treatments. The goal is to see if the drug is safe, tolerable, and effective in shrinking or controlling these tumors.

What this could mean

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

Active substance
LG00313112, an oral drug designed to target tumors with a specific TP53 Y220C mutation
What this could lead to
If successful, this could lead to a new targeted treatment for several hard-to-treat cancers that share this specific genetic mutation.
What could go wrong
This is an early-stage trial, so the drug may not work as hoped or may cause side effects. Success in a small group may not translate to broader benefits.

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 250 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Apr 2033

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. Males and females aged 18 years or older 2. Diagnosed locally advanced unresectable or metastatic solid tumor with a TP53 Y220C mutation. 3. Documented disease progression during or after the most recent line of therapy. In addition, must be refractory to or intolerant of standard of care therapy or have no standard therapy. 4. Measurable disease per RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Adequate organ function. Exclusion Criteria: 1. Investigational therapy or anti-cancer therapy within 21 days or 5 half-lives prior to the first dose of study drug. 2. Radiotherapy within 14 days prior to the first dose of study drug. 3. Known brain metastases (Exception: Brain metastases are permitted if the participant is neurologically stable), leptomeningeal disease or carcinomatous meningitis. 4. Uncontrolled pleural effusion, pericardial effusion, or ascites. 5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease 6. Serious infections requiring intravenous antibiotics within 14 days of first dose of study drug. 7. Active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection 8. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease 9. History of prior organ transplant 10. Currently receiving strong Cytochrome P4503A (CYP3A4) inhibitors or inducers

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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.

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