Testing SSGJ-707 with chemotherapy for metastatic colorectal cancer
A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients
This study is testing a new treatment called SSGJ-707 with chemotherapy to see if it helps people with metastatic colorectal cancer feel better compared to another treatment option.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Industry-sponsored |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06493760 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of SSGJ-707 in combination with chemotherapy for patients with metastatic colorectal cancer. It consists of two parts: the first part assesses different dosing regimens of SSGJ-707 alongside standard chemotherapy, while the second part compares SSGJ-707 with bevacizumab, another chemotherapy agent. The goal is to determine the best treatment approach for first-line therapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed metastatic colorectal cancer and a good performance status.
Not a fit: Patients with uncontrolled central nervous system metastases or significant adverse reactions to prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with metastatic colorectal cancer.
How similar studies have performed: While similar studies have explored treatments for metastatic colorectal cancer, the specific combination of SSGJ-707 with chemotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and/or females over age 18 2. Histologically and/or cytologically documented metastatic colorectal cancer confirmed . 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>=12 weeks. 5. Signed informed consent form. Exclusion Criteria: 1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0). 3. Inadequate organ or bone marrow function. 4. Pregnant or breast-feeding woman. 5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Where this trial is running
Shanghai, Shanghai Municipality
- Liu Tianshu — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.