A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers

Korábbi kezelés

• 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.
• Prior or current non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy.
• Presence of gastrointestinal perforation and/or fistula, intra-abdominal abscess within 6 months before the first dose.

Más betegség

• For colorectal cancer: Patients with known MSI-H or dMMR.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• History of severe bleeding tendency or coagulation dysfunction.
• Subjects with known active tuberculosis (TB).
• Known history of severe allergy to any component of the trial drug, or history of severe allergic reaction to chimeric or humanized antibodies.
• Other conditions that, in the opinion of the investigator, may increase study-related risks or interfere with the interpretation of study results.

Egyéb

• For gastric/gastroesophageal junction adenocarcinoma: HER2-positive (defined as IHC 3+, or IHC 2+ with ISH-positive).
• Presence of brainstem, meningeal metastases, spinal cord metastases, or compression.

• 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).
• Has bone marrow, kidney, liver, blood and clotting test results required per protocol.
• Female subjects of childbearing age had a negative serum pregnancy test within 7 days before the first dose. Male and female subjects of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until at least 120 days after the last use of study drug and for at least 180 days after the last use of chemotherapy drugs or bevacizumab. During this period, women are not lactating, male subjects are not allowed to freeze or donate sperm, and female subjects are not allowed to donate eggs or retrieve eggs for personal use.