NCT05938296

oHSV2-PD-L1/CD3-BsAb Administered Via Intratumoral Injection

A Phase 1, Open-label Study of BS006, an Oncolytic Virus, Administered by Intratumoral Injection in Patients With Advanced/Metastatic Solid Tumors

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Binhui Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a Phase 1, multi-center, open-label, dose escalation followed by the recommended phase 2 dose (RP2D) expansion study to characterize safety, tolerability, biodistribution, virus shedding and preliminary efficacy of intratumoral injection of BS006 in patients with advanced solid tumors.

Detailed description

Eligible patients are those who have measurable solid tumors as detected by CT or MRI that have persisted, recurred, or metastasized despite therapy. Patients must have histologically confirmed advanced and/or metastatic melanoma, cutaneous squamous cell carcinoma and other solid tumors with palpable, visible or ultrasound detectable lesions. Also, patients with solid tumors that are refractory to standard therapy and for which no existing conventional therapy are eligible. Melanoma patients who were previously treated with IMLYGIC (Talimogene laherparepvec, T-Vec) but did not achieve an optimal response to T-Vec are eligible to receive BS006. The study will be conducted in 2 parts as described below. Both parts will consist of a screening period of up to 28 days, a treatment period and a follow-up period (safety and long-term follow up). Treatment period of Part 1 will include an initial treatment period (3 doses of BS006) and an optional extended treatment period (repeated every 2 weeks). Subjects will be treated for up to 12 months.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BS006 Injection	BS006 will be given every two weeks, and up to 4mL in each treatment. There will be three dose levels: 1×10\^6 CCID50/mL, 5×10\^6 CCID50/mL, 1×10\^7 CCID50/mL.

Timeline

• Start date: 2023-12-19
• Primary completion: 2026-12-19
• Completion: 2026-12-19
• First posted: 2023-07-10
• Last updated: 2025-11-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study