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MelanomaPhase 1/2NCT04616443

OH2 Injection in Combination With HX008 for Melanoma.

A Phase 1/2 study testing OH2 injection and HX008 injection in people with Melanoma, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Melanoma
What is being tested?
OH2 injection and HX008 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Dec 2020to 30 Nov 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • (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.

Who cannot join

  • 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.
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  • 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;
  • Skin diseases that do not require systemic treatment;
  • Any other disease that does not re-occur without external triggers.
  • Concurrent medical condition requiring the use of cortisol (>10mg/day prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment, except for inhalation or topical corticosteroids no more than 10 mg/day prednisone or equivalent.
  • The researchers believe that there is any reason why the patient is not suitable to participate in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JUN GUO, PHD contact

86-010-88140650

guoj307@126.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100010

    Jun Guo, PHD, 86-010-88140650, guoj307@126.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

The trial is a phase Ib study evaluating the safety and efficacy of OH2 injection combined with HX008 injection in patients with Melanoma.

In the Phase Ib dose escalation trial, two doses (1x10e6, 1x10e7 CCID50/mL) of OH2 will be combined with HX008(at a fixed dose of 200mg) will be tested.

In the Phase Ib dose expansion trial, OH2(1x10e7 CCID50/mL) will be injected individually in the first week, followed by every two weeks while HX008(200 mg) will be injected every three weeks after the first injection which will be in the second week.

Blood samples will be collected and radiological imaging will be performed to evaluate safety and efficacy during the trial. Besides, patients will be subjected to cutaneous swabs, and blood/urine/feces sampling to determine virus shedding. Participating patients will be evaluated for objective response rate, progression free survival and overall survival.

Conditions
Melanoma
Being tested
OH2 injection, HX008 injection
Keywords
Oncolytic Virus
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OH2 injectionBiological

    Oncolytic Type 2 Herpes Simplex Virus

  • HX008 injectionBiological

    Recombinant humanized anti-PD-1 monoclonal antibody of injection

Study groups in NCT04616443
Study groupRoleWhat they receive
Dose escalationExperimentalThe 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.
Receives: Biological: OH2 injection; Biological: HX008 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 21 days after treatment

Secondary outcomes (6)

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

    Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1.

    Measured: 18 months

  2. The immunoreactivity of OH2 injection and HX008 injection.

    Detection of increased systemic immune Response markers in peripheral blood mononuclear cells by flow cytometer.Detection of complement C3, C4 titer.

    Measured: 18 months

  3. The immunogenicity of OH2 injection and HX008 injection.

    The immunogenicity of OH2 is evaluated by detection of anti-HSV2 antibodies and anti-GM-CSF antibodies in the blood.The immunogenicity of HX008 is evaluated by detection of anti-PD-1 antibodies in blood by ADA.

    Measured: 18 months

  4. The biodistribution and biologic effect of OH2 injection.

    The biodistribution of OH2 injection as determined by the concentration of OH2 in blood, urine and feces of participating patients.The biologic effect of OH2 injection as determined by the GM-CSF RNA quantification in fine needle aspiration(FNA) of patients.Expression of GM-CSF in FNA.The original result unit is copies/ul.

    Measured: 18 months

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

    Cmax.

    Measured: 18 months

  6. Explore the changes in peripheral blood and tumor tissue immune-related indicators during treatment.

    Peripheral blood T lymphocyte subtype.The ratio of CD4/CD8 in blood lymphocytes. PD-L1 expression in tumor tissue.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start1 Dec 2020
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04616443
Sponsor's protocol ID
OH2-I-ST-03
Status last verified
Jul 2025
First submitted
31 Aug 2020
Last updated
24 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OH2 injection and HX008 injection in people with Melanoma, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JUN GUO, PHD (86-010-88140650, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of dose-limiting toxicity (DLT) of OH2 injection in combination with HX008 injection in patients with melanoma (time frame: 21 days after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04616443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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