NCT06283121

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

A Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Combination With SOX and Toripalimab in Patients With Peritoneal Metastases From Gastric Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study intends to enroll Her2-negative subjects with first-line treatment of peritoneal metastasis from gastric cancer. Subjects will be treated with BioTTT001 intraperitoneal perfusion combined with SOX and toripalimab after completing the screening period, and the subjects will first receive BioTTT001 monotherapy treatment with BioTTT001 1×10\^10 viral particle (VP) intraperitoneal perfusion (P.I.), D1 and D3, and enter the combination therapy stage 7 days (±1d) after the first dose of BioTTT001.Subjects will be treated with the regimen as follows: BioTTT001 injection, 1×10\^10 VP P.I., D1；toripalimab 160mg intravenous (i.v.), D1; Oxaliplatin 130mg/m\^2 i.v. , D1 ; Tegafur 40\~60mg Bis in die（b.i.d.） Peroral（p.o.）D1\~D14; 3 weeks per cycle.

Conditions

• Gastric Cancer, Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	BioTTT001 intraperitoneal infusion	Monotherapy lead-in phase: BioTTT01 1×10\^10 VP, i.p., D1 and D3; Combination therapy phase: BioTTT01 1×10\^10 VP, i.p., D1 and D3, 3 weeks per cycle
DRUG	SOX regimen	Combination therapy phase: Oxaliplatin 130 mg，i.v., D1 and D3, 3 weeks per cycle; Tegafur 40\~60mg b.i.d. p.o. D1\~D14; 3 weeks per cycle
DRUG	toripalimab	Combination therapy phase: toripalimab 160mg i.v. D1, 3 weeks per cycle.

Timeline

• Start date: 2024-04-02
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2024-02-28
• Last updated: 2024-02-29