NCT07462143

A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer

A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)

Detailed description

Primary objective in Phase II: To preliminarily evaluate the efficacy of RC148 combined with chemotherapy as first - line treatment for unresectable or metastatic CRC. Primary objective in Phase III: To evaluate the efficacy of RC148 combined with chemotherapy compared with bevacizumab combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.

Conditions

• Colorectal (Colon or Rectal) Cancer

Interventions

Type	Name	Description
DRUG	RC148 (Dose 1) plus Capecitabine and Oxaliplatin	RC148 (Dose 1) plus Capecitabine and Oxaliplatin
DRUG	RC148 (Dose 2) plus Capecitabine and Oxaliplatin	RC148 (Dose 2) plus Capecitabine and Oxaliplatin

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-12-31
• Completion: 2030-12-31
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

19 sites across 1 country: China