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OH2 Injection in Solid Tumors

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

About this trial

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.

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 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.

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.).

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • OH2 injection

    Biological/Vaccine

    Oncolytic Type 2 Herpes Simplex Virus

  • Keytruda

    Drug

    Anti-PD-1 antibody

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Dose expansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months
3

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

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months
3

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

Time frame
12 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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