Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Infections

Skin and Connective Tissue Diseases

Rare Diseases

Pancreatic Neoplasms

Herpes Simplex

Virus Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Molgramostim

Sargramostim

OH2 injection will be administered at 1E+07 CCID50/mL .

OH2 injection

This phase Ib/II study evaluates the safety and efficacy of OH2 in patients with locally advanced/metastatic pancreatic cancer who have failed first-line standard treatment.

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.

OH2 injection ≤ 4 mL, administered by intratumoral injection of EUS-FNA, administered on the first day of the first cycle, every 3 weeks thereafter, administered on the 1st day of each cycle ± 3 days, continuous administration does not more than 6 treatment cycles.

OH2 Oncolytic Viral Therapy in Pancreatic Cancer

Phase Ib/II Study of OH2 Injection, an Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor, in Pancreatic Cancer

Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1. The assessment result is the number and proportion of subjects with complete response + partial response.

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.

Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1. The assessment result is the number and proportion of subjects with complete response + partial response + stable disease.

Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1. The time from the first assessment of complete response or partial response to the first assessment of disease progression or death from any cause.

Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1. Time from start of treatment to disease progression.

Binhui Biopharmaceutical Co., Ltd.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

OH2 dosage: 1x10e7 CCID50/mL Administration：intratumoral injection Frequency：once two weeks

OH2: Oncolytic Type 2 Herpes Simplex Virus

Shaogang Wang, MD

This Ⅱ study evaluates the safety and efficacy of intratumoral injection of OH2 in locally advanced or metastatic bladder cancer.

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.

This is a phase Ⅱ study evaluating the efficacy and safety of OH2 in locally advanced or metastatic bladder cancer.

BH-OH2-017 is a single-arm,multicenter clinical trial. The OH2 injection will be delivered once two weeks. In the maintenance treatment period, OH2(1x10e7 CCID50/mL) will be delivered once a month.

Adverse events (AEs) are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).

Radiographic imaging studies are performed using computed tomography or magnetic resonance imaging. Measurement of cutaneous or subcutaneous lesions are conducted with calipers. Evaluation of response are performed by the investigators using both the RECIST version 1.1 and the iRECIST criteria.

OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer

Efficacy and Safety Study of Oncolytic Virus (OH2) Intratumoral Injection in Locally Advanced or Metastatic Bladder Cancer a Phase Ⅱ Clinical Trial

The assessment result is the number and proportion of subjects with complete response + partial response.

The assessment result is the number and proportion of subjects with complete response + partial response + stable disease.

Time after OH2 administration to clinical and radiographic disease progression will be evaluated.

The overall survival for each patient receiving OH2 will be calculated

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antibodies

Antibodies, Monoclonal

Immunoglobulins

The 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.

Recombinant humanized anti-PD-1 monoclonal antibody of injection

HX008 injection

JUN GUO, PHD

Jun Guo, PHD

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.

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.

OH2 Injection in Combination With HX008 for Melanoma.

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

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.

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

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

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.

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.

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

Non-Muscle Invasive Bladder Neoplasms

Neoplasms, Glandular and Epithelial

This arm include two doses (1x10e6, 1x10e7 CCID50/mL) of OH2 injection，the 1x10e6 CCID50/mL dose group should be delivered before the 1x10e7 CCID50/mL dose group.

JianZhong Shou, MD

This phase Ⅰb/Ⅱ study evaluates the safety and efficacy of OH2 for adjuvant therapy in non-muscle-invasive bladder cancer after first-line prophylactic intravesical instillation therapy.

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.

This is a phase Ⅰb/Ⅱ study evaluating the safety and efficacy of OH2 in non-muscle-invasive bladder cancer.

BH-OH2-016 is a single-arm,multicenter clinical trial. After screening, The treatment period includes induction treatment period and maintenance treatment period. In the induction treatment period, OH2 will be delivered once two weeks. In the maintenance treatment period, OH2 will be delivered once a month. In this trial, two doses (1x10e6, 1x10e7 CCID50/mL) of OH2 will be delivered intravesical instillation，and the 1x10e6 CCID50/mL dose group should be delivered before the 1x10e7 CCID50/mL dose group.

Adverse events (AEs) are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).Urine cytology/Cystoscopy/ultrasonography of urinary system will be used for disease recurrence examination.

OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer

Oncolytic Virus (OH2) Adjuvant Therapy After Transurethral Resection of Bladder Tumor in Non-Muscle-Invasive Bladder Cancer Who Have Failed First-line Prophylactic Intravesical Instillation Therapy: a Phase Ⅰb/Ⅱ Clinical Trial

All events with a Grade 3 or above toxicity (defined by the CTCAE v5.0) will be tabulated by event and by relationship to OH2.

The assessment result is the number and proportion of subjects with relapse free survival at 6 months.

The assessment result is the number and proportion of subjects with relapse free survival at 12 months.

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Central Nervous System Neoplasms

Nervous System Neoplasms

The dose-escalating phase of the phase I trial of OH2 injection is divided into two dose groups (10\^6 CCID50/mL and 10\^7 CCID50/mL).It will be administered by Ommaya reservoir injection, and the total amount of each dose in each dose group should not exceed 2ml according to the size of the tumor cavity.

Wenbin Li

In the first phase, it mainly explores the safety, tolerability and preliminary effectiveness of two doses of OH2 injection in the treatment of patients with recurrent central nervous system tumors; to evaluate the biodistribution and virus shedding of OH2 injection administered in the tumor cavity; to evaluate the level of anti-HSV2 antibody in patients when OH2 injection is administered intracavitary to tumor; to determine the phase II recommended dose (RP2D) of OH2 injection in the treatment of recurrent glioblastoma.

Phase IIa, to evaluate the preliminary efficacy of OH2 injection in the treatment of patients with recurrent glioblastoma after surgery, and to further evaluate the safety of OH2 in the treatment of relapsed glioblastoma.

OH2 Oncolytic Viral Therapy in Central Nervous System Tumors

A Clinical Study of Oncolytic Virus (OH2) Injection in the Treatment of Patients Undergoing Surgery After Recurrence of Central Nervous System Tumors

If ≥2/6 subjects developed DLT, the previous dose group was MTD

Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol

The overall survival for each patient receiving OH2 will be calculated.

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Dose 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.

Keytruda

Jun Guo, PH.D

Jun Guo, P.HD

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.

OH2 Injection in Solid Tumors

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

Liver Neoplasms

Liver Diseases

Hematinics

Liver Extracts

Administration：intratumoral injection Frequency：once every 3 weeks

OH2 injection administered by transcatheter Intraarterial infusion

chuansheng zheng, MD

Chuansheng Zheng, MD

An open-label dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of OH2 injection via transcatheter Intraarterial infusion in patients with advanced hepatocellular carcinoma

OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients With Advanced Liver Cancer

A Phase I, Open-label, Dose Escalation Study to Evaluate the Safety ,Tolerance and Pharmacokinetics of OH2 Via Transcatheter Intraarterial Infusion in Patients With Advanced Liver Cancer

According to the NCI-CTCAE 5.0 grading standard

Subjects will get OH2 injection every two weeks, and up to 8mL for each treatment. There will have three virus titers: 1×10\^6 CCID50/mL, 5×10\^6 CCID50/mL, 1×10\^7 CCID50/mL.

OH2 injection will be given intratumorally, and Q2W.

OH2 Injection

Weiyu Yang

This study will be a Phase 1, multi-center, open-label, dose escalation followed by the recommended phase 2 dose (RP2D) expansion study to characterize safety, tolerability, biodistribution, virus shedding and preliminary efficacy of intratumoral injection of OH2 in patients with locally advanced/metastatic solid tumors.

Eligible patients are those who have measurable solid tumors as detected by CT or MRI that have persisted, recurred, or metastasized despite therapy. Part 1 and Part 2 Cohort A will include patients who have solid tumors with cutaneous/subcutaneous tumor lesions, such as melanoma, cutaneous squamous cell carcinoma, and cutaneous/subcutaneous metastasis from pancreatic cancer, colorectal cancer, breast cancer, etc. Part 2 Cohort B will include patients who have visceral tumors. Patients who were previously treated with IMLYGIC (Talimogene laherparepvec, T-Vec) but did not achieve an optimal response to T-Vec are eligible to receive OH2 if otherwise per protocol (refer to Section 5 for detailed enrollment criteria). The study will be conducted in 2 parts as described below. Both parts will consist of a screening period of up to 28 days, a treatment period and a follow-up period (safety and long-term follow up). Treatment period of Part 1 will include an initial treatment period (namely DLT (dose-limiting toxicity) observation period, 3 doses of OH2) and an optional extended treatment period (repeated every 2 weeks).

OH2 Administered by Intratumoral Injection

A Phase 1, Open-label Study of OH2, an Oncolytic Virus, Administered by Intratumoral Injection in Patients With Advanced/Metastatic Solid Tumors

To estimate the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of OH2

Determination of the ORR is calculated based on the proportion of patients achieving complete response (CR) or partial response (PR) using the RECIST v1.1 and modified WHO response criteria as assessed.

DCR is defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD).

Granulocyte macrophage colony stimulating factor (GM-CSF) mRNA expression in fine needle aspirate (FNA)(Only for Part 1)

OH2 DNA copy in swab of surface of injected lesion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
OH2 Oncolytic Viral Therapy in Pancreatic Cancer	NCT04637698	Pancreatic Canc...	OH2 injection	18 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer	NCT05248789	Advanced Bladde...	OH2 injection	18 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Injection in Combination With HX008 for Melanoma.	NCT04616443	Melanoma	OH2 injection HX008 injection	18 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer	NCT05232136	Non-muscle-inva...	OH2 injection	18 Years - 80 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Oncolytic Viral Therapy in Central Nervous System Tumors	NCT05235074	Central Nervous...	OH2 injection	18 Years -	Binhui Biopharmaceutical Co., Ltd.
OH2 Injection in Solid Tumors	NCT04386967	Solid Tumor Melanoma	OH2 injection Keytruda	18 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer	NCT05232136	Non-muscle-inva...	OH2 injection	18 Years - 80 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Oncolytic Viral Therapy in Central Nervous System Tumors	NCT05235074	Central Nervous...	OH2 injection	18 Years -	Binhui Biopharmaceutical Co., Ltd.
OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer	NCT05248789	Advanced Bladde...	OH2 injection	18 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Injection in Combination With HX008 for Melanoma.	NCT04616443	Melanoma	OH2 injection HX008 injection	18 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients With Advanced Liver Cancer	NCT05698459	Advanced Liver ...	OH2 injection	18 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Administered by Intratumoral Injection	NCT05954091	Solid Tumor	OH2 Injection	18 Years -	Binhui Biopharmaceutical Co., Ltd.

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