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

NCT07752875 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: LG-FCCL001
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ovarian Cancer; Colorectal Cancer; Esophageal Cancer; Breast Cancer; Head and Neck Cancer; Small Cell Lung Cancer; Endometrial Cancer; Non Small Cell Lung Cancer; Pancreatic Cancer; Locally Advanced Unresectable or Metastatic Solid Tumor

Keywords

Solid Tumor, TP53 Y220C Mutation

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (15)

• Phase 1: Maximum observed plasma concentration (Cmax)

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

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

  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)

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

• Phase 1: Terminal half-life (T1/2)

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

• Phase 1: ORR

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

Study Arms (1)

Dose escalation and Backfill

EXPERIMENTAL

Drug: LG00313112

Interventions

LG00313112 DRUG

LG00313112 will be administered orally once daily (QD)

Dose escalation and Backfill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Esophageal Neoplasms; Breast Neoplasms; Endometrial Neoplasms; Head and Neck Neoplasms; Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Esophageal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Uterine Diseases; Pancreatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): October 31, 2032
• Study Completion (Estimated): April 30, 2033
• Last Updated: August 7, 2026

Record last verified: 2026-07