NCT04466254

Efficacy and Safety Study of Combination of CPGJ602 and Chemotherapy, in First Line, With Wild KRAS/NRAS/BRAF in Metastatic Colorectal Cancer

A Phase II Study Evaluating the Efficacy and Safety of Combination of CPGJ602 and Chemotherapy as First Line Treatment in KRAS/NRAS/BRAF Wild-type, Metastatic Colorectal Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of the combination of CPGJ602 and chemotherapy in subjects with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer.

Detailed description

This is an open label, randomized, positive control, phase II study to treat subjects with KRAS/NRAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into three arms consist of CPGJ602 (2 weeks/cycle) + mFOLFOX6, CPGJ602 (1 week/cycle) + mFOLFOX6, and cetuximab (1 week/cycle) + mFOLFOX6 at a ratio of 2:2:1. This study is conduct to assess the efficacy and safety of three treatments for patients.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CPGJ602	Q2W/QW iv
DRUG	cetuximab	QW iv

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-12-30
• Completion: 2022-03-30
• First posted: 2020-07-10
• Last updated: 2021-08-23

Locations

1 site across 1 country: China