Can a pill restore the Body's tumor suppressor to fight multiple cancers?
NCT ID NCT07752875
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2033
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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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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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.
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