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OncoMatch/Clinical Trials/NCT04616443

OH2 Injection in Combination With HX008 for Melanoma.

Is NCT04616443 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including OH2 and HX008 for melanoma.

Phase 1/2RecruitingBinhui Biopharmaceutical Co., Ltd.NCT04616443Data as of May 2026

Treatment: OH2 · HX008This 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.

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: conventional treatment

Patients who have failed in conventional treatment (including PD-1 monotherapy) (disease progression or intolerance) or who have failed in previously assisted PD-1 monotherapy (last assisted PD-1 treatment relapse or metastasis within 6 months)

Cannot have received: other experimental therapies or antiviral therapy

Other experimental therapies or antiviral therapy are used or are being used within 4 weeks of treatment

Lab requirements

Blood counts

WBC≥3.0×10^9/L, ANC≥2.0×10^9/L, PLT≥100×10^9/L, Hb≥90 g/L

Kidney function

BUN and Scr. were in the upper limit of 1.5 times of the normal value

Liver function

TBIL≤ 1.5 times the upper limit of the normal value; ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value.

(a) WBC≥3.0×10^9/L,ANC≥2.0×10^9/L ,PLT≥100×10^9/L,Hb≥90 g/L; (b) BUN and Scr. were in the upper limit of 1.5 times of the normal value; (c) TBIL≤ 1.5 times the upper limit of the normal value. (d) ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value. (e) Coagulation function is normal (PT and APPT are within 1.5 times of the upper limit of normal value).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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