NCT06384248

Phase II Clinical Study of LTC004 in Patients With Advanced Sarcoma

An Open, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of LTC004 Alone in Patients With Locally Advanced or Metastatic Sarcoma Who Have Failed 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, tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcoma；Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission or SD lasting \>12 weeks, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004

Conditions

• Unresectable or Metastatic Sarcoma

Interventions

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

Timeline

• Start date: 2024-04-26
• Primary completion: 2025-12-28
• Completion: 2025-12-28
• First posted: 2024-04-25
• Last updated: 2024-04-25