NCT07752875Not yet recruitingPhase 1
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
LG Chem0 sites250 target enrollmentStarted: December 1, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 250
- Primary Endpoint
- Phase 1: Frequency of treatment-emergent adverse events (TEAEs)
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •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
Arms & Interventions
Dose escalation and Backfill
Experimental
Intervention: LG00313112 (Drug)
Outcomes
Primary Outcomes
Phase 1: Frequency of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 12 months after treatment initiation
Phase 1: Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Up to 21 days after treatment
Phase 1: Frequency of serious adverse events (SAEs)
Time Frame: Up to 12 months after treatment initiation
Phase 2: objective response rate (ORR)
Time Frame: Up to 12 months after treatment initiation
Secondary Outcomes
- 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: Maximum observed plasma concentration (Cmax)(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))
- Phase 1: Time to Response (TTR)(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 1: Duration of response (DOR)(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 1: Disease Control Rate (DCR)(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 1: Progression-free survival (PFS)(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 2: Frequency of TEAEs(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 2: Frequency of SAEs(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 2: DOR(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 2: DCR(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 2: PFS(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
- Phase 2: Overall survival (OS)(Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2))
Investigators
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