NCT07752875Not yet recruitingPhase 1/2
A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation
A Phase 1/2, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
This is a first-in-human, Phase 1/2, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of LG00313112 in participants with advanced solid malignancies harboring a TP53 Y220C mutation
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 31 Oct 2032
- Lead sponsor
- LG Chem
- Diseases
- Head and neck cancer, Endometrial cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07752875
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 250
- From 1 Dec 2026 to the primary completion date, 31 Oct 2032
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Investigational therapy or anti-cancer therapy within 21 days or 5 half-lives prior to the first dose of study drug.
- Radiotherapy within 14 days prior to the first dose of study drug.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease
- History of prior organ transplant
- Currently receiving strong Cytochrome P4503A (CYP3A4) inhibitors or inducers
Other illness
- Known brain metastases (Exception: Brain metastases are permitted if the participant is neurologically stable), leptomeningeal disease or carcinomatous meningitis.
- Serious infections requiring intravenous antibiotics within 14 days of first dose of study drug.
- Active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease
Other
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
Who the study is looking for
- Males and females aged 18 years or older
- Diagnosed locally advanced unresectable or metastatic solid tumor with a TP53 Y220C mutation.
- 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.
- Measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.