Actively Recruiting
Phase 2 Study of SSGJ-707 Combined with Chemotherapy for First-Line Treatment of Metastatic Colorectal Cancer
Led by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Updated on 2024-09-19
130
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of SSGJ-707, a bispecific antibody, in combination with chemotherapy as a first treatment option for patients with metastatic colorectal cancer. This Phase 2 study aims to assess the safety and effectiveness of different dosing schedules of SSGJ-707, including comparison with bevacizumab combined with chemotherapy. The trial is sponsored by Sunshine Guojian Pharmaceutical Shanghai Co., Ltd. and focuses on treatment outcomes over a one-year period. The study has two parts the first part tests different doses of SSGJ-707 combined with chemotherapy regimens XELOX or mFOLFOX6 the second part compares SSGJ-707 plus chemotherapy against bevacizumab plus chemotherapy. Some participants may receive SSGJ-707 alone as monotherapy. Treatments are given according to assigned groups without randomization or masking. Chemotherapy drugs used include oxaliplatin, capecitabine, calcium folinate, and 5-fluorouracil. Participants will be involved for up to 12 months for assessing response rate and safety, with a 24-month follow-up for progression-free survival. Researchers will monitor the patients health status, side effects, and treatment tolerability regularly. Safety evaluations and tumor response assessments will be conducted to measure the impact of the study treatments. The total participation time may vary depending on individual response and study procedures.
CONDITIONS
Brief Title
A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
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