NCT06384235

Phase II Clinical Study of LTC004 in Patients With mCRC

An Open, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of LTC004 Monotherapy in Patients With Metastatic Colorectal Cancer Who Have Failed Third-Line and Above Standard Treatment

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Letolab · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II clinical study to evaluate the safety and antitumor activity of LTC004 in patients with locally advanced or metastatic CRC，Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission，proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004

Conditions

• Locally Advanced or Metastatic CRC

Interventions

Type	Name	Description
DRUG	LTC004	LTC004,45μg/kg,IV,Day 1,Q3W;

Timeline

• Start date: 2024-04-25
• Primary completion: 2025-08-23
• Completion: 2025-08-23
• First posted: 2024-04-25
• Last updated: 2024-04-25