Actively Recruiting
A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients
Led by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Updated on 2024-09-19
130
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older
- Histologically or cytologically confirmed metastatic colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- Signed informed consent form
You will not qualify if you...
- Known uncontrolled or symptomatic central nervous system metastatic disease
- Prior anticancer therapy adverse events greater than grade 1 (except alopecia and fatigue)
- Inadequate organ or bone marrow function
- Pregnant or breastfeeding women
- Known allergies, hypersensitivity, or intolerance to SSGJ-707
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive SSGJ-707 alone or in combination with chemotherapy drugs as their first-line treatment for metastatic colorectal cancer.
Trial Site Locations
Total: 1 location
1
Liu Tianshu
Shanghai, Shanghai Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
7
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