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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат LG00313112
  LG00313112 will be administered orally once daily (QD)

Первичные конечные точки

• Phase 1: Number of participants with dose-limiting toxicities (DLTs) [Срок оценки: Up to 21 days after treatment]
• Phase 1: Frequency of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 12 months after treatment initiation]
• Phase 1: Frequency of serious adverse events (SAEs) [Срок оценки: Up to 12 months after treatment initiation]
• Phase 2: objective response rate (ORR) [Срок оценки: Up to 12 months after treatment initiation]

Вторичные конечные точки (12)

• Phase 1: Maximum observed plasma concentration (Cmax) [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 1: Time to maximum observed plasma concentration (Tmax) [Срок оценки: 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) [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 1: Terminal half-life (T1/2) [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 1: ORR [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 1: Time to Response (TTR) [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 1: Duration of response (DOR) [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 1: Disease Control Rate (DCR) [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 1: Progression-free survival (PFS) [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 2: Frequency of TEAEs [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 2: Frequency of SAEs [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
• Phase 2: DOR [Срок оценки: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07752875 · LG-FCCL001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗