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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLG Chem

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LG00313112

Treatment groups

250 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators