A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestina… (NCT07233850) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers
China300 participantsStarted 2025-11
Plain-language summary
This study is a multicenter, open-label, phase II clinical trial evaluating the combination of SSGJ-706 with standard therapy for advanced gastrointestinal tumors. Its objective is to assess the safety, tolerability, and antitumor activity of SSGJ-706 in combination with standard treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Volunteer to participate in this study, willing to follow all trial procedures, and sign the informed consent form (ICF).
✓. Age 18-75 years old, male or female.
✓. Has a life expectancy of at least 3 months
✓. ECOG score of 0-1.
✓. Locally advanced or metastatic tumors of the digestive system that cannot be curatively resected and cannot be treated with radical chemoradiotherapy, including gastric/gastroesophageal junction adenocarcinoma, colorectal cancer, pancreatic ductal adenocarcinoma, and oesophageal cancer.
✓. No prior systemic therapy in the locally advanced unresectable/metastatic setting.
✓. Has at least 1 measurable lesion per RECIST version 1.1.
✓. Willing to provide a paraffin-embedded (FFPE) specimen or an unstained histopathological section (preferably a newly obtained tumor tissue sample).
Exclusion criteria
✕. For gastric/gastroesophageal junction adenocarcinoma: HER2-positive (defined as IHC 3+, or IHC 2+ with ISH-positive).
✕. For colorectal cancer: Patients with known MSI-H or dMMR.
✕. Presence of brainstem, meningeal metastases, spinal cord metastases, or compression.
✕. Presence of active central nervous system (CNS) metastases; Subjects with previously treated brain metastases (such as surgery, radiotherapy) are allowed to enroll if they are clinically stable for at least four weeks after treatment (until the first dose of study drug) and corticosteroids are discontinued 3 days before the first dose of study drug; Subjects with untreated, asymptomatic brain metastases can be enrolled.
✕. Previous immunotherapy, including immune checkpoint inhibitors (e.g., PD-l/L1 antibody, anti-CTLA-4 antibody, anti-TIGIT antibody, anti-LAG3 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, OX40 antibody, etc.), immune cell therapy and any other treatment targeting the mechanism of anti-tumor immune action.
✕. Adverse reactions caused by previous anti-tumor therapy need to be restored to grade ≤1 (as judged by NCI-CTCAE 5.0 criteria), except for alopecia and fatigue.
✕. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
✕. Prior or current non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy.