NCT07382531

OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors

An Open-label, Dose-escalation Phase Ib/II Clinical Trial of Intratumoral Injection of OH2 Injection in Combination With BS006 Injection for the Treatment of Advanced Solid Tumors.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Binhui Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

BS008-001 is a multicenter, open-label phase Ib /II trial in heavily pre-treated patients with advanced solid tumors. Patients received biweekly sequential intratumoral injections of OH2 (fixed dose: 10⁷ CCID₅₀/mL) followed by BS006 (dose escalation: 10⁶-10⁷ CCID₅₀/mL), with identical volumes being injected at the same lesion. The primary endpoint is safety and tolerability; secondary endpoints included efficacy outcomes assessed by RECIST 1.1/iRECIST.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	OH2+BS006	Patients received biweekly sequential intratumoral injections of OH2 (fixed dose: 10⁷ CCID₅₀/mL) followed by BS006 (dose escalation: 10⁶-10⁷ CCID₅₀/mL), with identical volumes being injected at the same lesion.

Timeline

• Start date: 2023-09-07
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2026-02-02
• Last updated: 2026-02-04

Locations

1 site across 1 country: China