NCT06322563

Combination of LTC004 and Regorafenib to Treat Patients With Advanced/Metastatic CRC

An Open, Single-arm, Phase II Clinical Study Evaluating the Safety and Initial Efficacy of LTC004 in Combination With Regorafenib in the Treatment of Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• 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 combination with regorafenib in patients with mCRC. A safety introductory trial was conducted to receive LTC004 in combination with regorafenib before starting the formal trial. After completing a 28-day safety assessment, safety will be confirmed before entering the formal trial phase. Further evaluation of the safety and efficacy of LTC004 in combination with regorafenib in the treatment of mCRC

Conditions

• Advanced/Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	LTC004+regorafenib	LTC004,90μg/kg,IV,Day 1,Q3W; Regorafenib:Orally once daily for the first 21 days of each cycle, with 28 days as 1 cycle. Cycle 1 was dose-escalation with a starting dose of 80 mg/d, increasing by 40 mg per week until 160 mg/d, i.e., 80 mg/d in week 1 (D1\~D7), 120 mg/d in week 2 (D8\~D14), and 160 mg/d in week 3 (D15\~D21);

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

1 site across 1 country: China