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
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.
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.
Single group
LG00313112
DrugLG00313112 will be administered orally once daily (QD)
Phase 1: Number of participants with dose-limiting toxicities (DLTs)
Phase 1: Frequency of treatment-emergent adverse events (TEAEs)
Phase 1: Frequency of serious adverse events (SAEs)
Phase 2: objective response rate (ORR)
Phase 1: Maximum observed plasma concentration (Cmax)
Phase 1: Time to maximum observed plasma concentration (Tmax)
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)
Phase 1: Terminal half-life (T1/2)
This trial is not recruiting at the moment. You can still explore other options:
