A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mut… (NCT07752875) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation
250 participantsStarted 2026-12-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Number of participants with dose-limiting toxicities (DLTs)
Timeframe: Up to 21 days after treatment
2
Phase 1: Frequency of treatment-emergent adverse events (TEAEs)
Timeframe: Up to 12 months after treatment initiation
3
Phase 1: Frequency of serious adverse events (SAEs)
Timeframe: Up to 12 months after treatment initiation
4
Phase 2: objective response rate (ORR)
Timeframe: Up to 12 months after treatment initiation