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OH2 Injection in Combination With HX008 for Melanoma.

ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBinhui Biopharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • OH2 injection

    Biological/Vaccine

    Oncolytic Type 2 Herpes Simplex Virus

  • HX008 injection

    Biological/Vaccine

    Recombinant humanized anti-PD-1 monoclonal antibody of injection

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Dose escalationExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
21 days after treatment

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Binhui Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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