NCT06147505

XS005 Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM)

Clinical Study of Evaluating the Safety and Initial Efficacy of XS005 Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM)

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Dushu Lake Hospital Affiliated to Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this clinical study is to evaluate the safety of XS005 injection; to determine the maximum tolerated dose . Furthermore, initial efficacy will be examined.

Detailed description

Treatment on this study includes eight XS005 infusions over an 16 week period. The study will evaluate the safety, feasibility and maximum tolerated dose (MTD) of XS005 using a 3+3 study design . The total study duration will be 2 years.

Conditions

• Tumor

Interventions

Type	Name	Description
BIOLOGICAL	XS005 Injection	Treatment on this study includes XS005 infusions over an 16 week period. Phase 1： dose escalation (3+3); Phase 2 : dose of recommended phase 2 dose(RP2D).

Timeline

• Start date: 2023-10-29
• Primary completion: 2025-11-02
• Completion: 2025-12-29
• First posted: 2023-11-27
• Last updated: 2024-10-29

Locations

1 site across 1 country: China