This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer.
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;
History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration;
Patients with central nervous system metastases with clinical symptoms;
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;
China Medical University, China
Lead sponsor
Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Collaborator