A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LG00313112.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Small Cell Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug LG00313112
LG00313112 will be administered orally once daily (QD)
Primary outcome measures
- Phase 1: Number of participants with dose-limiting toxicities (DLTs) [Time frame: Up to 21 days after treatment]
- Phase 1: Frequency of treatment-emergent adverse events (TEAEs) [Time frame: Up to 12 months after treatment initiation]
- 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 outcome measures (12)
- Phase 1: Maximum observed plasma concentration (Cmax) [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 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)]
- 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)]
- Phase 1: Terminal half-life (T1/2) [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
- Phase 1: ORR [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
- Phase 1: Time to Response (TTR) [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
- Phase 1: Duration of response (DOR) [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
- Phase 1: Disease Control Rate (DCR) [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
- Phase 1: Progression-free survival (PFS) [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
- Phase 2: Frequency of TEAEs [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
- Phase 2: Frequency of SAEs [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
- Phase 2: DOR [Time frame: Approximately 12 months per participant (Approximately 77 months for Phase 1 and Phase 2)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07752875 · LG-FCCL001