NCT06205082

A Phase I Clinical Trial to Evaluate LIT-00814 Tablets in Patients With Advanced Solid Tumor

A Multicenter, Open Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of LIT-00814 Tablets in Patients With Advanced Solid Tumor/Esophageal Cancer.

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: LittDD Medicines Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of LIT-00814 tablets. This study includes two parts: Ia phase (i.e. dose escalation) and Ib phase (i.e. dose expansion).

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	LIT-00814	LIT-00814 is an oral tablet.

Timeline

• Start date: 2023-10-14
• Primary completion: 2025-10-30
• Completion: 2026-06-30
• First posted: 2024-01-12
• Last updated: 2024-03-01

Locations

1 site across 1 country: China