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Not yet recruitingNCT07752875Updated Aug 7, 2026

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

A Phase 1/2 interventional study of LG00313112 in Ovarian Cancer, Small Cell Lung Cancer and Non Small Cell Lung Cancer, sponsored by LG Chem. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by LG Chem · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

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.

02

Conditions studied

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

Keywords

  • Solid Tumor, TP53 Y220C Mutation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Males and females aged 18 years or older
  2. Diagnosed locally advanced unresectable or metastatic solid tumor with a TP53 Y220C mutation.
  3. 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.
  4. Measurable disease per RECIST v1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  6. Adequate organ function.

Exclusion criteria

Exclusion Criteria:

  1. Investigational therapy or anti-cancer therapy within 21 days or 5 half-lives prior to the first dose of study drug.
  2. Radiotherapy within 14 days prior to the first dose of study drug.
  3. Known brain metastases (Exception: Brain metastases are permitted if the participant is neurologically stable), leptomeningeal disease or carcinomatous meningitis.
  4. Uncontrolled pleural effusion, pericardial effusion, or ascites.
  5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease
  6. Serious infections requiring intravenous antibiotics within 14 days of first dose of study drug.
  7. Active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection
  8. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease
  9. History of prior organ transplant
  10. Currently receiving strong Cytochrome P4503A (CYP3A4) inhibitors or inducers
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Dose escalation and Backfill

    Drug: LG00313112

Interventions

  • DrugLG00313112

    LG00313112 will be administered orally once daily (QD)

05

What researchers measure

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)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07752875
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Oct 31, 2032 (estimated)
Completion
Apr 30, 2033 (estimated)
Last update
Aug 7, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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