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Solid TumorPhase 1/2NCT04386967

OH2 Injection in Solid Tumors

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor, Melanoma
What is being tested?
OH2 injection and Keytruda
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
22 Nov 2018to 2 Jun 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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 and/ or cytology; breast cancer, gastrointestinal adenocarcinoma, liver cancer, cervical cancer, malignant melanoma, head and neck tumors, Priority inclusion in soft tissue sarcomas (mainly for melanoma patients at the dose extension phase).
  • The absence of a conventional effective treatment or treatment failure or recurrence by a conventional method.
  • Male or female patients, aged 18 ≤ 75 years (including boundary value), general physical condition score ECOG 0 ≤ 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.
  • Those who have undergone major surgery will have to undergo surgery for four weeks.
  • There is at least one measurable lesion that is suitable for intratumoral injection. According to RECIST version 1.1, it is determined that at least once the CT or MRI examination shows the tumor lesion, it is possible to measure the tumor focus. The measured tumor focus is defined as the longest diameter ≥ 10 mm and the scanning thickness is not more than 5.0 mm. For lymph node lesions, the short diameter is ≥ 15 mm.
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  • There is no serious dysfunction of the main organs.
  • (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.).
  • History of primary grape-film melanoma or other malignant tumors in the 3 years prior to treatment. (use of combination drugs only)
  • Past or present immunodeficiency diseases. (use of combination drugs only)
  • 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)
  • Autoimmune diseases requiring systemic treatment (e.g. steroids or immunosuppressants) during the first 2 years of treatment, such as autoimmune pneumonia, glomerular nephritis, vasculitis and other symptoms of autoimmune diseases; Except for wind or child asthma. (use of combination drugs only)
  • Have uncontrolled primary or brain metastatic tumors.
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  • Suffering from uncontrolled mental illness, infectious diseases.
  • The lesions cannot meet the requirements of injection capacity 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.
  • Other clinical studies have been taken in the past 4 weeks.
  • Allergy to herpes virus and drug ingredients.
  • 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.

China1 site

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100010

Other trials in China

About this study

Official title: Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors

This 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.

Being tested
OH2 injection, Keytruda
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

  • KeytrudaDrug

    Also called pembrolizumab

    Anti-PD-1 antibody

Study groups in NCT04386967
Study groupRoleWhat they receive
Dose expansionExperimentalDose expansion trial comprises of 2 cohorts. In cohort 1, OH2 injection will be administered at 1x10e7CCID50/mL . In cohort 2, OH2 injection will be administered at 1x10e7CCID50/mL in combination with Keytruda injection, an anti-PD-1 antibody, and the first doses of the two anti-tumor agents will be administered on the same day.
Receives: Biological: OH2 injection; Drug: Keytruda

What is being measured

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

  1. Further evaluation of dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of OH2 in patients with solid tumors

    Measured: 12 months

  2. The dose-limiting toxicity (DLT) of OH2 injection and Keytruda in patients with solid tumors

    Measured: 12 months

  3. The maximum-tolerated dose (MTD) of OH2 injection in combination with Keytruda in patients with solid tumors

    Measured: 12 months

Secondary outcomes (3)

  1. The response rate of patients with solid tumors receiving OH2 injection monotherapy and OH2 injection in combination with Keytruda

    Measured: 12 months

  2. The biodistribution of OH2 injection as determined by the concentration of OH2 in blood, urine and feces of participating patients

    Measured: 12 months

  3. The immunogenicity of OH2 injection as determined by the detection of antibodies in response to OH2 and GM-CSF

    Measured: 12 months

Timeline

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

  1. First posted13 May 2020
  2. Study start22 Nov 2018
  3. Primary completion2 Jun 2026
  4. Study completion2 Jun 2026

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386967
Sponsor's protocol ID
OH2-I-ST-01
Status last verified
Aug 2026
First submitted
13 Apr 2020
Last updated
6 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang X, Tian H, Chi Z, Si L, Sheng X, Hu H, Gu X, Li S, Li C, Lian B, Zhou L, Mao L, Tang B, Yan X, Wei X, Li J, Liu B, Guo J, Kong Y, Cui C. Oncolytic virus OH2 extends survival in patients with PD-1 pretreated melanoma: phase Ia/Ib trial results and biomarker insights. J Immunother Cancer. 2025 Feb 6;13(2):e010662. doi: 10.1136/jitc-2024-010662.

    PubMed 39915002

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OH2 injection and Keytruda in people with Solid Tumor and 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 6 Aug 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Further evaluation of dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of OH2 in patients with solid tumors (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT04386967, which also lists 1 linked publication.

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 6 Aug 2026.

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OH2 Injection in Solid Tumors (NCT04386967) | AzTrials