Clinical trial · Interventional

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

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

NCT07752875CI-TRIAL-00121109not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (10)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Endometrial Cancer	Malignant Endometrial Neoplasm	CURATED_BROADER	0.80
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Locally Advanced Unresectable or Metastatic Solid Tumor	—	UNRESOLVED	—
Non Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
LG00313112	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Dose escalation and Backfill
interventionNames
1. Drug: LG00313112

Primary outcomes (4)

measure
Phase 1: Number of participants with dose-limiting toxicities (DLTs)
timeFrame
Up to 21 days after treatment
measure
Phase 1: Frequency of treatment-emergent adverse events (TEAEs)
timeFrame
Up to 12 months after treatment initiation
measure
Phase 1: Frequency of serious adverse events (SAEs)
timeFrame
Up to 12 months after treatment initiation

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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:

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

References

Publications (0)

Data not yet available

No reference posted for this study.