OH2 Injection in Melanoma

NCT05868707 | Recruiting Phase 3

• 1 other identifier: BH-OH2-020
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 30

Brief Summary

To evaluate the efficacy of OH2 injection in patients with unresectable or metastatic melanoma who have failed at least second-line standard therapy, using investigator-selected salvage chemotherapy or best supportive care (BSC) as controls.

Conditions

Melanoma

Keywords

Oncolytic virus

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival is defined as the interval from first dose to death from any cause.

  From date of randomization until the date of death from any cause，assessed up to 3 years

Secondary Outcomes (5)

• Objective response rate (ORR)

  Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study, assessed up to 3 years

• Disease control rate (DCR)

  Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study, assessed up to 3 years

• Progression-free survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

• Durable Response Rate (DRR)

  Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study，assessed up to 3 years

• Duration of Response (DOR)

  Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study，assessed up to 3 years

Study Arms (2)

OH2

EXPERIMENTAL

OH2: 10\^7 CCID50/mL intratumoral injection, once every 2 weeks;

Drug: OH2

Salvage chemotherapy or best supportive care

ACTIVE COMPARATOR

Salvage chemotherapy (single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum) or best supportive care selected by the investigator

Drug: Salvage chemotherapy or best supportive care

Interventions

OH2 DRUG

Oncolytic Type 2 Herpes Simplex Virus

OH2

Salvage chemotherapy or best supportive care DRUG

single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum

Salvage chemotherapy or best supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old, male or female;
• Stage III or stage IV melanoma that has been definitively diagnosed by pathology and/or cytology and has failed at least second-line standard therapy (including chemotherapy, immunotherapy, and targeted therapy for those with genetic mutations) (progression to unresectable or metastatic melanoma within 6 months after the end of adjuvant therapy or during adjuvant therapy, This adjuvant therapy can be considered as advanced first-line therapy) for patients with unresectable or metastatic melanoma;
• The overall percentage of subjects with mucosal melanoma will not exceed 22%;
• Eastern Oncology Consortium (ECOG) physical condition score ECOG 0 \~ 1;
• The expected survival time is more than 3 months;
• At least 4 weeks after completion of previous antitumor therapy (including chemotherapeutic/radiotherapy, targeted therapy, immunotherapy) (at least 2 weeks after completion of previous bone radiotherapy, at least 6 weeks after withdrawal of chemotherapy using nitrosourea and mitomycin), and have recovered from adverse reactions of previous treatment (≤ grade 1 or baseline, except hair loss), and 4 weeks after surgery for major surgery;
• At least one measurable target lesion was present according to RECIST 1.1 criteria. There are lesions suitable for intratumoral injection. Measurable tumor lesions were defined as longest diameter ≥10 mm and scanning thickness less than 5.0 mm. For lymph node lesions, short diameter ≥15 mm.
• Asymptomatic central nervous system metastases, or treated asymptomatic brain metastases, must be examined by computed tomography (CT) or magnetic resonance imaging (MRI) for no disease progression, stable for at least 3 months, and without steroid medication for at least 4 weeks;
• No severe dysfunction of major organs; Laboratory tests meet the following criteria:
• WBC≥3.0×109 / L, ANC≥2.0×109 / L (no correction by granulocyte colony stimulating factor \[G-CSF\] or granulocyte macrophage colony stimulating factor \[GM-CSF\] within 14 days prior to screening), PLT≥100×109 /L (do not receive platelet infusion or thrombopoietin \[TPO\], thrombopoietin (TPO) receptor agonist or interleukin-11 \[IL-11\] within 14 days before screening), Hb≥90 g/L (do not receive blood transfusion or erythropoietin \[EPO\] correction within 14 days before screening);
• Blood BUN and blood creatinine within the range of 1.5 times the upper limit of normal value;
• TBIL≤ 1.5 times the upper limit of normal (total bilirubin \<2×ULN in subjects with Gilbert syndrome, or total bilirubin \<3×ULN in subjects with indirect bilirubin indicating extrahepatic cause of total bilirubin elevation);
• ALT and AST≤ 2.5 times the upper limit of normal value; Patients with liver metastases do not exceed 5 times the upper limit of normal;
• Normal coagulation function (PT, APPT within 1.5 times the upper limit of normal);
• Female subjects of childbearing age must have tested serum-negative for pregnancy before receiving the first trial drug;

You may not qualify if:

• Severe medical conditions, including uncontrolled diabetes with medication, severe infections requiring systematic treatment, and active digestive tract ulcers;
• Clinically important cardiovascular and cerebrovascular diseases exist, including:
• Severe or uncontrolled heart disease requiring treatment, congestive heart failure rated III or IV by the New York Cardiology Association, unstable angina that cannot be controlled by medication, myocardial infarction in the last 6 months, ECG QTc interval: Severe arrhythmias requiring medication (other than atrial fibrillation or paroxysmal supraventricular tachycardia) ≥450 milliseconds in men and 470 milliseconds in women;
• Patients with heart stents in place within 6 months;
• Inadequately controlled hypertension, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
• History of primary uveal melanoma or other malignancies within 5 years prior to treatment (except early resection of cervical carcinoma in situ and skin cancer in situ);
• A large amount of pleural fluid or ascites with clinical symptoms or symptomatic management;
• Bone metastases (stable metastases controlled by treatment can be ruled out) or the presence of active, clinical BMS;
• Have an active autoimmune disease that has required systemic treatment within the past 2 years (e.g. with disease-regulating drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency) does not count as systemic therapy;
• A history of immunodeficiency (HIV antibody positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Patients with active hepatitis B or hepatitis C: HbsAg or HBCAB-positive patients with HBV DNA copy number positive (limit of quantitative detection is 500IU/ml); HBV DNA (negative for HBV-DNA/below the hospital standard for quantitative testing) must be tested in the screening of such patients; Patients who tested positive for HCV antibodies were enrolled in this study only if HCV RNA test results were negative;
• There is an active TB infection or other infectious disease that requires systematic treatment;
• The subject has a known history of psychotropic substance abuse, alcoholism, or drug use;
• Other investigational agents or antiviral therapies have been or are being used within 4 weeks prior to treatment, except for hepatitis B patients on ongoing treatment who may be treated with Entecavir, Tenofovir dipifuroxide fumarate, or adefovir dipivoxil;
• Use of investigational drug within 4 weeks prior to initial dosing;

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (30)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

NOT YET RECRUITING

Fujian Cancer Hosptial

Fuzhou, Fujian, 350000, China

RECRUITING

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530000, China

NOT YET RECRUITING

Hainan Cancer Hospital

Haikou, Hainan, 570100, China

NOT YET RECRUITING

The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

NOT YET RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

RECRUITING

The first hospital of Jilin University

Changchun, Jilin, 130000, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

NOT YET RECRUITING

Liaoning Cancer Hospital ＆ Institute

Shenyang, Liaoning, 116000, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

The Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

NOT YET RECRUITING

Weifang People's Hospital

Weifang, Shandong, 261000, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Tianjin Medical University Cancer Institute ＆ Hospital

Tianjin, Tianjin Municipality, 300000, China

NOT YET RECRUITING

The Affiliated Cancer Hospital, Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650000, China

NOT YET RECRUITING

Cancer Hospital Of The University Of Chinese Academy Of Sciences Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 39915002 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Wentao Xu

CONTACT

15111009972; xuwentao@binhui-bio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 22, 2023
• Study Start: March 8, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

CN (30)