NCT06363552

A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer

A Study to Evaluate the Preliminary Safety and Efficacy of SC0191 as Single Agent or in Combination With Bevacizumab or 5-FU/LV in Advanced Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Tianshu Liu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SC0191	The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle.
DRUG	SC0191 + Bevacizumab	1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Bevacizumab injection is administered intravenously at a dose of 5mg/kg on day 1 and day 15 of each treatment cycle.
DRUG	SC0191 + 5-FU/LV	1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Calcium folinate 400mg/m2 intravenous infusion (over 2 hours or more), on the first day, followed by 5-fluorouracil 400mg/m2 intravenous bolus injection, then continuous intravenous infusion of 1200mg/m2/day for 2 days.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-04-01
• Completion: 2025-12-01
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: China