Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07752875

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Ovarian Cancer Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Locally Advanced Unresectable or Metastatic Solid Tumor Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Non Small Cell Lung Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

LG00313112

Drug

LG00313112 will be administered orally once daily (QD)

Primary outcomes

  1. Phase 1: Number of participants with dose-limiting toxicities (DLTs)

    Time frame: Up to 21 days after treatment

  2. Phase 1: Frequency of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 12 months after treatment initiation

  3. Phase 1: Frequency of serious adverse events (SAEs)

    Time frame: Up to 12 months after treatment initiation

  4. Phase 2: objective response rate (ORR)

    Time frame: Up to 12 months after treatment initiation

Secondary outcomes

  1. Phase 1: Maximum observed plasma concentration (Cmax)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  2. Phase 1: Time to maximum observed plasma concentration (Tmax)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  3. 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)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  4. Phase 1: Terminal half-life (T1/2)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  5. Phase 1: ORR

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  6. Phase 1: Time to Response (TTR)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  7. Phase 1: Duration of response (DOR)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  8. Phase 1: Disease Control Rate (DCR)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  9. Phase 1: Progression-free survival (PFS)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  10. Phase 2: Frequency of TEAEs

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  11. Phase 2: Frequency of SAEs

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  12. Phase 2: DOR

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  13. Phase 2: DCR

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  14. Phase 2: PFS

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

  15. Phase 2: Overall survival (OS)

    Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2032
Study completion
2033
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.