NCT05940181

A Safety and Efficacy Study of XH001 Combined With Sintilimab Injection in Advanced Solid Tumors

A Safety and Efficacy Study of XH001 (Neoantigen Cancer Vaccine) Combined With Sintilimab Injection in Advanced Solid Tumors

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: jianming xu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated, single-center, open label, single-arm dose escalation study of XH001 (neoantigen tumor vaccine) in combination with sintilimab for advanced solid tumors. To evaluate the safety and tolerability of XH001 combined with sintilimab in subjects with advanced solid tumors, and preliminarily evaluate the efficacy of the combination therapy in subjects with advanced solid tumors. The study will include pre-screening period (about 12 weeks), screening period (Weeks -4 to Day 1, and Week -1 to Day -1 will be baseline period), treatment period (Day 1 to Week 16 will be combination treatment period, followed by sintilimab monotherapy), and follow-up period. After signing pre-screening informed consent, tumor tissue and blood samples will be collected for gene sequencing, neoantigen prediction and vaccine preparation. During vaccine preparation, subjects will receive sintilimab (200mg, intravenous infusion, 21-day per cycle) or other antitumor therapy as deemed appropriate by the investigator. Subjects who sign and provide formal informed consent will enter the formal screening period, and qualified subjects will enter treatment period. During the treatment period, subjects will receive 6 cycles of XH001+ sintilimab, followed by sintilimab monotherapy (sintilimab will be administered for up to 18 cycles or for 1 year, whichever comes first). The dose escalation phase follows standard 3+3 design. 9-12 subjects are expected to be enrolled at 2 given dose level.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	XH001+ sintilimab	During treatment period, subjects will receive 6 cycles of XH001+ sintilimab, followed by sintilimab monotherapy (sintilimab will be administered for up to 18 cycles or for 1 year, whichever comes first).

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-05-01
• Completion: 2025-12-01
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

1 site across 1 country: China