Small Cell Lung Cancer / Ovarian Cancer / LG00313112 · Phase 1/2 Trial

A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned first-in-human Phase 1/2 study of LG00313112, a TP53 Y220C mutation-targeting drug, in patients with advanced solid malignancies. The study has not yet begun recruitment and no results are available. The primary endpoints are safety and tolerability in Phase 1, and objective response rate in Phase 2.

What was studied

Phase 1/2, Interventional, Single Group, Open label, Treatment purpose. Ovarian Cancer, Small Cell Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Esophageal Cancer, Breast Cancer, Endometrial Cancer, Head and Neck Canc…; age from 18 Years. Intervention: Dose escalation and Backfill. n = 250.

Key findings

Safety

No comparator arm; safety and efficacy cannot be evaluated relative to standard of care or placebo.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record for a planned first-in-human Phase 1/2 study with no results posted; enrollment has not yet begun.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Phase 1: Number of participants with dose-limiting toxicities (DLTs) (assessed at Up to 21 days after treatment); Phase 1: Frequency of treatment-emergent adverse events (TEAEs) (assessed at Up to 12 months after treatment initiation); Phase 1: Frequency of serious adverse events (SAEs) (assessed at Up to 12 months after treatment initiation); Phase 2: objective response rate (ORR) (assessed at Up to 12 months after treatment initiation)

DesignPhase 1/2, Interventional, Single Group, Open label, Treatment purpose

PopulationOvarian Cancer, Small Cell Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Esophageal Cancer, Breast Cancer, Endometrial Cancer, Head and Neck Canc…; age from 18 Years

Sample size250

InterventionDose escalation and Backfill

Reported figures

Quoted from the source exactly as published.

Planned enrollment250

Phase 1 primary endpointNumber of participants with dose-limiting toxicities (DLTs), up to 21 days after treatment

Phase 1 primary endpointFrequency of treatment-emergent adverse events (TEAEs), up to 12 months after treatment initiation

Phase 1 primary endpointFrequency of serious adverse events (SAEs), up to 12 months after treatment initiation

Phase 2 primary endpointObjective response rate (ORR), up to 12 months after treatment initiation

Caveats

This is a registry record only; no results have been posted or published.
Study has not yet begun recruitment (status: NOT_YET_RECRUITING).
Open-label design (unblinded) limits assessment of bias for efficacy outcomes.
No comparator arm; safety and efficacy cannot be evaluated relative to standard of care or placebo.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

First-in-human Phase 1/2 open-label design with safety and efficacy endpoints planned.

Directness

insufficient

No results reported; cannot assess directness of any outcome.

Consistency

insufficient

Single-arm, planned study; no comparator or replication data available.

Risk of bias

insufficient

Study not yet recruiting; conduct and bias assessment cannot be performed.

Sample adequacy

moderate

Estimated enrollment 250 participants; adequate for Phase 1/2 dose escalation and preliminary efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07752875). This is a study registration, not published results. Lead sponsor: LG Chem. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Ovarian Cancer, Small Cell Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Esophageal Cancer, Breast Cancer, Endometrial Cancer, Head and Neck Cancer, Pancreatic Cancer, Locally Advanced Unresectable or Metastatic Solid Tumor. Interventions: DRUG: LG00313112. Primary outcome measures: Phase 1: Number of participants with dose-limiting toxicities (DLTs) , Up to 21 days after treatment; Phase 1: Frequency of treatment-emergent adverse events (TEAEs) , Up to 12 months after treatment initiation; Phase 1: Frequency of serious adverse events (SAEs) , Up to 12 months after treatment initiation; Phase 2: objective response rate (ORR) , Up to 12 months after treatment initiation. Brief 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

LG ChemNCT07752875Small Cell Lung CancerOvarian CancerLG00313112Non Small Cell Lung Cancer