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
Study Identifier:
LG-FCCL001
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Will Be Recruiting
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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
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancers
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Small Cell Lung
Head & Neck
Solid Tumor
Endometrial
Digestive & Intestinal
Neuroendocrine
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Dose escalation and Backfill
Read More
Drug: Drug: LG00313112
Drug: LG00313112 will be administered orally once daily (QD)
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting
Requirements information
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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Will Be Recruiting
Condition(s) Treated at Site
Breast Cancers
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Small Cell Lung
Head & Neck
Solid Tumor
Endometrial
Digestive & Intestinal
Neuroendocrine