OH2 Injection in Combination With HX008 for Melanoma.

NCT04616443 | Recruiting Phase 1

• 1 other identifier: OH2-I-ST-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Keywords

Oncolytic Virus

Outcome Measures

Primary Outcomes (1)

• Evaluation of dose-limiting toxicity (DLT) of OH2 injection in combination with HX008 injection in patients with melanoma

  According to the version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events, the adverse events during the entire study period are evaluated to observe the dose-limiting toxicity.

  21 days after treatment

Secondary Outcomes (6)

• The response rate of patients with melanoma receiving OH2 injection in combination with HX008 injection

  18 months

• The immunoreactivity of OH2 injection and HX008 injection.

  18 months

• The immunogenicity of OH2 injection and HX008 injection.

  18 months

• The biodistribution and biologic effect of OH2 injection.

  18 months

• The pharmacygenic dynamics (PK) characteristics of HX008 injections in the case of HX008 injections combined with OH2 injections.

  18 months

Study Arms (1)

Dose escalation

EXPERIMENTAL

The HX008 injection is combined with OH2 injections at 10ˆ6 and 10ˆ7 CCID50/mL at a fixed dose of 200 mg, respectively. OH2 will be injected individually in the first week, followed by every two weeks while HX008 will be injected every three weeks after the first injection which will be in the second week.

Biological: OH2 injection; Biological: HX008 injection

Interventions

OH2 injection BIOLOGICAL

Oncolytic Type 2 Herpes Simplex Virus

Dose escalation

HX008 injection BIOLOGICAL

Recombinant humanized anti-PD-1 monoclonal antibody of injection

Dose escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The non-operative stage III or stage IV malignant tumor patients with clear diagnosis by pathology.
• 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).
• Patients with Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1, expected survival time more than 3 months.
• Prior anti-tumor treatment (including endocrine, chemical/ radiotherapy,targeted therapy) was over 4 weeks (more than 6 weeks of discontinuation using nitroso-and mitomycin-based chemotherapy) and was recovered to grade 1 from the side effects of prior treatment.
• There is at least one measurable lesion that is suitable for intratumoral injection. The measured tumor focus is defined as the longest diameter ≥ 5 mm.
• Asymptomatic central nervous system metastasis, or treated asymptomatic brain metastasis patients, must be examined by a computerized fault scan (CT) or MRI for disease-free progression, stable for at least 3 months, and at least 4 weeks without steroid medication.
• (a) WBC≥3.0×109／L，ANC≥2.0×109／L ，PLT≥100×109／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).
• Female subjects and their spouses received effective contraceptives during and within 3 months of treatment.
• Subjects with herpes in the reproductive organs needed three months after the end of herpes.
• The informed consent was voluntarily signed and the expected compliance was good.

You may not qualify if:

• Severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active digestive tract ulcer, abnormal immune function (including, but not limited to, rheumatoid arthritis, lupus erythematosus, Sjogren's syndrome, etc.).
• Significant surgery is expected to be performed during the 28-day screening period during the study period.
• Patients had active infections or unexplained fevers (over 38.5℃)during screening and before the first drug use.
• Past or present immunodeficiency diseases.
• The lesions do not meet the requirements of injection capacity(1ml) in the tumor body.
• Pregnant or lactating women.
• Other experimental therapies or antiviral therapy are used or are being used within 4 weeks of treatment.
• Allergy to herpes virus and drug ingredients.
• History of primary grape-film melanoma or other malignant tumors in the 5 years prior to treatment.
• History of tuberculosis, or have tuberculosis at the time of screening.
• Suffering from sudden lung disease, intersex lung disease, intersex pneumonia, pulmonary fibrosis, acute lung disease, radioactive pneumonia etc.
• Patients with active autoimmune diseases or with a history of autoimmune diseases that may relapse, except for:
• Type I diabetes with stable condition after taking a fixed dose of insulin;
• Hypothyroidism;
• Controlled celiac disease;

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

JUN GUO, PHD

CONTACT

86-010-88140650; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: November 5, 2020
• Study Start: December 1, 2020
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CN (1)