A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer

Prior treatment

• Patients who have been treated with high-dose systemic corticosteroids (prednisone \> 10 mg/day or equivalent doses) or other immunosuppressants within 2 weeks before the first dose of BioTTT001;
• Previous treatment with other adenovirus drugs within 28 days before the first dose of BioTTT001;
• Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 14 days before the first dose of BioTTT001;
• Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia );
• Known allergy to the investigational drug or its components;
• Patients with prior organ transplants;

Other illness

• History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration;
• Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia);
• Patients with active infection requiring systemic anti-infective therapy;
• HBsAg positive, and blood HBV DNA≥100 IU/mL; anti-HCV positive; HIV positive; active syphilis;
• Patients with active tuberculosis or drug-induced interstitial lung disease；
• Patients with active inflammatory bowel disease ；

Other

• Patients with central nervous system metastases with clinical symptoms;
• Patients with primary immunodeficiency;
• NYHA≥ grade 3；
• Pregnant or lactating women;
• Other reasons judged by the investigator.

• Male or female, age≥ 18 years；
• Patients with a diagnosis of gastric cancer by histopathology or cytology, accompanied by peritoneal metastasis, without systemic therapy, or for patients who have received neoadjuvant/adjuvant chemotherapy before, the time from last treatment to disease recurrence \> 6 months;
• Tumor Her2 negative (IHC 0/1＋ or IHC 2＋ and FISH-).
• At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors （RECIST) 1.1;
• WBC≥3.0×10\^9 /L; ANC≥1.5×10\^9 /L; HB≥90 g/L; PLT≥75×10\^9 /L;
• ALT and AST≤3×ULN (≤5×ULN with liver metastasis); ALB≥20g/L; Cr≤1.5×ULN or CCr\>50 mL/min; TBIL≤1.5×ULN; APTT≤1.5×ULN and INR or PT≤1.5×ULN (without anticoagulation therapy)
• LVEF≥50%; male QTc≤450 mms, female QTc≤470 mms;
• ECOG 0\~1；
• Expected survival ≥ 3 months;
• Consent to contraception；
• Understand and voluntarily sign a written ICF and be willing to comply with all trial requirements.