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OncoMatch/Clinical Trials/NCT04386967

OH2 Injection in Solid Tumors

Is NCT04386967 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including OH2 and Keytruda for solid tumor.

Phase 1/2RecruitingBinhui Biopharmaceutical Co., Ltd.NCT04386967Data as of May 2026

Treatment: OH2 · KeytrudaThis 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Melanoma

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: PD-1/PD-L1/PD-L2 inhibitor

Treated with PD-1/PD-L1 or PD-L2 monoantigens or inhibitors that have been used or used in the past. (use of combination drugs only)

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 ≤ 1.5x ULN

Liver function

TBIL ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN (≤ 5x ULN with liver metastasis)

(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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