A Phase 1/2 interventional study of LG00313112 in Ovarian Cancer, Small Cell Lung Cancer and Non Small Cell Lung Cancer, sponsored by LG Chem. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by LG Chem · Phase 1/2, Interventional, and Treatment
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
The objective of Phase 1 is to determine the biologically active dose range/maximum-tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of LG00313112 and to characterize the safety and tolerability of LG00313112.
The objective of Phase 2 is to evaluate the antitumor activity, safety, and tolerability of LG00313112 at the dose levels selected based on the Phase 1 results.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 250 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: LG00313112
LG00313112 will be administered orally once daily (QD)
Phase 1: Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 21 days after treatment
Phase 1: Frequency of treatment-emergent adverse events (TEAEs)
Time frame: Up to 12 months after treatment initiation
Phase 1: Frequency of serious adverse events (SAEs)
Time frame: Up to 12 months after treatment initiation
Phase 2: objective response rate (ORR)
Time frame: Up to 12 months after treatment initiation
Phase 1: Maximum observed plasma concentration (Cmax)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Time to maximum observed plasma concentration (Tmax)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Area under the concentration-time curve from time zero to time of last quantifiable concentration or in one dosing interval (AUC0-T, AUCtau)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Terminal half-life (T1/2)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: ORR
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Time to Response (TTR)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Duration of response (DOR)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Disease Control Rate (DCR)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Progression-free survival (PFS)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: Frequency of TEAEs
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: Frequency of SAEs
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: DOR
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: DCR
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: PFS
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: Overall survival (OS)
Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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