NCT05954091

OH2 Administered by Intratumoral Injection

A Phase 1, Open-label Study of OH2, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced/Metastatic Solid Tumors

• Status: Not Yet Recruiting
• 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 OH2 in patients with locally advanced/metastatic 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. Part 1 and Part 2 Cohort A will include patients who have solid tumors with cutaneous/subcutaneous tumor lesions, such as melanoma, cutaneous squamous cell carcinoma, and cutaneous/subcutaneous metastasis from pancreatic cancer, colorectal cancer, breast cancer, etc. Part 2 Cohort B will include patients who have visceral tumors. 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 OH2 if otherwise per protocol (refer to Section 5 for detailed enrollment criteria). 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 (namely DLT (dose-limiting toxicity) observation period, 3 doses of OH2) and an optional extended treatment period (repeated every 2 weeks).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	OH2 Injection	OH2 injection will be given intratumorally, and Q2W.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2023-07-20
• Last updated: 2024-12-27

Regulatory

• FDA-regulated drug study