A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2: SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Males and/or females over age 18
• Histologically and/or cytologically documented metastatic colorectal cancer confirmed .
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival \>=12 weeks.
• Signed informed consent form.
Locations
Other Locations
China
Liu Tianshu
RECRUITING
Shanghai
Time Frame
Start Date: 2024-09-03
Estimated Completion Date: 2027-06
Participants
Target number of participants: 130
Treatments
Experimental: SSGJ-707(dose 1)+ XELOX
Experimental: SSGJ-707(dose 1)+ mFOLFOX6
Experimental: SSGJ-707(dose 2)+ XELOX
Experimental: SSGJ-707(dose 2)+ mFOLFOX6
Experimental: SSGJ-707+XELOX/mFOLFOX6
Active_comparator: Bevacizumab+XELOX/mFOLFOX6
Experimental: SSGJ-707 monotherapy
Related Therapeutic Areas
Sponsors
Leads: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.