Ovarian CancerPhase 1/2NCT07752875
A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation
A Phase 1/2 study testing LG00313112 in people with Ovarian Cancer and Small Cell Lung Cancer, run by LG Chem.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Small Cell Lung Cancer, Non Small Cell Lung Cancer
- What is being tested?
- LG00313112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Apr 2033
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Known brain metastases (Exception: Brain metastases are permitted if the participant is neurologically stable), leptomeningeal disease or carcinomatous meningitis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease
- Serious infections requiring intravenous antibiotics within 14 days of first dose of study drug.
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- Active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease
- History of prior organ transplant
- Currently receiving strong Cytochrome P4503A (CYP3A4) inhibitors or inducers
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Ovarian Cancer, Small Cell Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Esophageal Cancer, Breast Cancer
- Being tested
- LG00313112
- Keywords
- Solid Tumor, TP53 Y220C Mutation
- Medical subject headings
- Ovarian Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Esophageal Neoplasms, Breast Neoplasms, Endometrial Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LG00313112Drug
LG00313112 will be administered orally once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and Backfill | Experimental | Not described Receives: Drug: LG00313112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of participants with dose-limiting toxicities (DLTs)
Measured: Up to 21 days after treatment
Phase 1: Frequency of treatment-emergent adverse events (TEAEs)
Measured: Up to 12 months after treatment initiation
Phase 1: Frequency of serious adverse events (SAEs)
Measured: Up to 12 months after treatment initiation
Phase 2: objective response rate (ORR)
Measured: Up to 12 months after treatment initiation
Secondary outcomes (15)
Phase 1: Maximum observed plasma concentration (Cmax)
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Time to maximum observed plasma concentration (Tmax)
Measured: 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)
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Terminal half-life (T1/2)
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: ORR
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Time to Response (TTR)
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Duration of response (DOR)
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Disease Control Rate (DCR)
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 1: Progression-free survival (PFS)
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: Frequency of TEAEs
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: Frequency of SAEs
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: DOR
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: DCR
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: PFS
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Phase 2: Overall survival (OS)
Measured: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Oct 2032 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752875
- Sponsor's protocol ID
- LG-FCCL001
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07752875
- Acronym / sponsor ID
- LG-FCCL001
- Conditions
- Ovarian Cancer, Small Cell Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Esophageal Cancer, Breast Cancer
- Keywords
- Solid Tumor, TP53 Y220C Mutation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and Backfill | Experimental | Drug: LG00313112 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- Known brain metastases (Exception: Brain metastases are permitted if the participant is neurologically stable), leptomeningeal disease or carcinomatous meningitis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LG00313112LG00313112 will be administered orally once daily (QD) | Drug | Dose escalation and Backfill |
Primary outcome
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
15 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LG00313112 in people with Ovarian Cancer and Small Cell Lung Cancer, run by LG Chem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of participants with dose-limiting toxicities (DLTs) (time frame: Up to 21 days after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.