RecruitingPhase 1Phase 2NCT04616443

OH2 Injection in Combination With HX008 for Melanoma.

Phase Ib Study of the Combination Use of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) and HX008 Injection in the Treatment of Melanoma


Sponsor

Binhui Biopharmaceutical Co., Ltd.

Enrollment

60 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib study evaluates the safety and efficacy of OH2 in combination with HX008, an anti-PD-1 antibody, in patients with 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 is testing a combination of two treatments for advanced melanoma: OH2 (an oncolytic virus injected directly into tumors) and HX008 (an immune checkpoint blocker). It targets patients whose melanoma has stopped responding to standard immunotherapy treatments. **You may be eligible if...** - You have confirmed stage III or IV melanoma or another advanced solid tumor - Your cancer has not responded to or you could not tolerate standard treatments, including PD-1 immunotherapy - You are in good enough health (ECOG ≤ 1) with an estimated survival of more than 3 months - Your prior treatment side effects have mostly resolved (grade 1 or better) - You have at least one measurable tumor **You may NOT be eligible if...** - Your cancer is well-controlled on current treatment - You have significant organ function problems - You are pregnant or breastfeeding - You have active brain metastases requiring immediate treatment 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

BIOLOGICALHX008 injection

Recombinant humanized anti-PD-1 monoclonal antibody of injection


Locations(1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

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NCT04616443


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