OH2 Injection in Combination With HX008 for Melanoma.

STATUS

Recruiting
End date

Nov 30, 2022
participants needed

60
sponsor

Wuhan Binhui Biotechnology Co., Ltd.

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Updated on 5 January 2022

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measurable disease

metastasis

liver metastasis

mitomycin

targeted therapy

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.

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.

Details

Condition	Melanoma
Treatment	OH2 injection, HX008 injection
Clinical Study Identifier	NCT04616443
Sponsor	Wuhan Binhui Biotechnology Co., Ltd.
Last Modified on	5 January 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	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
	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
	The researchers believe that there is any reason why the patient is not suitable to participate in this trial
	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

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OH2 Injection in Combination With HX008 for Melanoma.