RecruitingPhase 1Phase 2NCT04386967

OH2 Injection in Solid Tumors

Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors


Sponsor

Binhui Biopharmaceutical Co., Ltd.

Enrollment

30 participants

Start Date

Nov 22, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma). OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests OH2, a modified herpes virus injected directly into tumors, to treat a variety of advanced solid cancers including breast cancer, gastrointestinal cancers, liver cancer, cervical cancer, melanoma, head and neck cancers, and soft tissue sarcoma. The virus is designed to infect and kill cancer cells while also stimulating the immune system. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced (stage III or IV) cancer of one of the target types that has not responded to standard treatment - You have at least one tumor that can be injected directly - Your overall health is reasonably good (ECOG 0-1) and your expected survival is more than 3 months - Your blood counts and major organ functions are within acceptable ranges **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have active herpes sores in the genital area (must wait at least 3 months after resolution) - You are pregnant or breastfeeding - You have severe uncontrolled medical conditions such as uncontrolled diabetes, uncontrolled high blood pressure, or active autoimmune disease - You have had another cancer in the past 3 years - You are allergic to herpes virus or any ingredients in the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOH2 injection

Oncolytic Type 2 Herpes Simplex Virus

DRUGKeytruda

Anti-PD-1 antibody


Locations(1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

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NCT04386967


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