A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation
- Sponsor
- LG Chem
- Study ID
- NCT07752875
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Breast Cancer
- Colorectal Cancer
- Endometrial Cancer
- Esophageal Cancer
- Head and Neck Cancer
- Locally Advanced Unresectable or Metastatic Solid Tumor
- Non Small Cell Lung Cancer
- Ovarian Cancer
- Pancreatic Cancer
- Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- LG00313112 — DRUGLG00313112 will be administered orally once daily (QD)
Study Details
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
Key Dates
- First listed
- Aug 7, 2026
- Start date
- Dec 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Oct 31, 2032
- Completion
- Apr 30, 2033
Study Design
- Enrollment
- 250 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose escalation and Backfill
Primary Outcome Measure
Phase 1: Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to 21 days after treatment ]
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