OH2 Administered by Intratumoral Injection

Solid Tumor Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Solid Tumor

• NCT number: NCT05954091
• Study type: Interventional
• Source: Binhui Biopharmaceutical Co., Ltd.
• Contact: Weiyu Yang
• Phone: +86 13122392686
• Email: yangweiyu@binhui-bio.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2023
• Completion date: January 1, 2026