OH2 Injection in Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Over 18 years old, male or female; 2. 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; 3. The overall percentage of subjects with mucosal melanoma will not exceed 22%; 4. Eastern Oncology Consortium (ECOG) physical condition score ECOG 0 ~ 1; 5. The expected survival time is more than 3 months; 6. 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; 7. 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. 8. 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; 9. No severe dysfunction of major organs; Laboratory tests meet the following criteria: 1. 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); 2. Blood BUN and blood creatinine within the range of 1.5 times the upper limit of normal value; 3. 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); 4. 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; 5. Normal coagulation function (PT, APPT within 1.5 times the upper limit of normal); 10. Female subjects of childbearing age must have tested serum-negative for pregnancy before receiving the first trial drug; 11. Female subjects of reproductive age and male subjects with partners of women of reproductive age received effective forms of contraception during and for 3 months after treatment; 12. For subjects with genital herpes, need 3 months after the end of herpes; 13. Voluntary signing of informed consent, expected compliance is good.

Exclusion Criteria:

1. Severe medical conditions, including uncontrolled diabetes with medication, severe infections requiring systematic treatment, and active digestive tract ulcers; 2. 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; 3.
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); 4. A large amount of pleural fluid or ascites with clinical symptoms or symptomatic management; 5. Bone metastases (stable metastases controlled by treatment can be ruled out) or the presence of active, clinical BMS; 6. 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; 7. A history of immunodeficiency (HIV antibody positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8. 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; 9. There is an active TB infection or other infectious disease that requires systematic treatment; 10. The subject has a known history of psychotropic substance abuse, alcoholism, or drug use; 11. 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; 12. Use of investigational drug within 4 weeks prior to initial dosing; 13. Had received live attenuated vaccine within 4 weeks prior to initial administration; 14. Pregnant or lactating women; 15. The investigator believed that the patient was not eligible to participate in the study for any reason.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05868707
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Binhui Biopharmaceutical Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

Experimental: OH2

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

Active Comparator: Salvage chemotherapy or best supportive care

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

Interventions

Drug: - OH2

Oncolytic Type 2 Herpes Simplex Virus

Drug: - Salvage chemotherapy or best supportive care

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking University Cancer Hospital, Beijing 1816670, Beijing Municipality 2038349, China

Status

Recruiting

Address

Peking University Cancer Hospital

Beijing 1816670, Beijing Municipality 2038349, 100010

Chongqing University Cancer Hospital, Chongqing 1814906, Chongqing Municipality 1814905, China

Status

Not yet recruiting

Address

Chongqing University Cancer Hospital

Chongqing 1814906, Chongqing Municipality 1814905, 400000

Fujian Cancer Hosptial, Fuzhou 1810821, Fujian 1811017, China

Status

Recruiting

Address

Fujian Cancer Hosptial

Fuzhou 1810821, Fujian 1811017, 350000

Guangzhou 1809858, Guangdong 1809935, China

Status

Not yet recruiting

Address

Dermatology Hospital of Southern Medical University

Guangzhou 1809858, Guangdong 1809935, 510000

Sun Yat-sen University Cancer Center, Guangzhou 1809858, Guangdong 1809935, China

Status

Not yet recruiting

Address

Sun Yat-sen University Cancer Center

Guangzhou 1809858, Guangdong 1809935, 510000

Nanning 1799869, Guangxi 1809867, China

Status

Not yet recruiting

Address

Guangxi Medical University Cancer Hospital

Nanning 1799869, Guangxi 1809867, 530000

Hainan Cancer Hospital, Haikou 1809078, Hainan 1809054, China

Status

Not yet recruiting

Address

Hainan Cancer Hospital

Haikou 1809078, Hainan 1809054, 570100

Shijiazhuang 1795270, Hebei 1808773, China

Status

Not yet recruiting

Address

The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital

Shijiazhuang 1795270, Hebei 1808773, 050000

Harbin 2037013, Heilongjiang 2036965, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Harbin Medical University

Harbin 2037013, Heilongjiang 2036965, 150000

The Third People's Hospital of Zhengzhou, Zhengzhou 1784658, Henan 1808520, China

Status

Recruiting

Address

The Third People's Hospital of Zhengzhou

Zhengzhou 1784658, Henan 1808520, 450000

Hubei Cancer Hospital, Wuhan 1791247, Hubei 1806949, China

Status

Not yet recruiting

Address

Hubei Cancer Hospital

Wuhan 1791247, Hubei 1806949, 430000

Wuhan 1791247, Hubei 1806949, China

Status

Not yet recruiting

Address

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan 1791247, Hubei 1806949, 430000

Hunan Cancer Hospital, Changsha 1815577, Hunan 1806691, China

Status

Recruiting

Address

Hunan Cancer Hospital

Changsha 1815577, Hunan 1806691, 410000

Nanjing Drum Tower Hospital, Nanjing 1799962, Jiangsu 1806260, China

Status

Recruiting

Address

Nanjing Drum Tower Hospital

Nanjing 1799962, Jiangsu 1806260, 210000

Nanchang 1800163, Jiangxi 1806222, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Nanchang University

Nanchang 1800163, Jiangxi 1806222, 330000

Jilin Cancer Hospital, Changchun 2038180, Jilin 2036500, China

Status

Recruiting

Address

Jilin Cancer Hospital

Changchun 2038180, Jilin 2036500, 130000

The first hospital of Jilin University, Changchun 2038180, Jilin 2036500, China

Status

Not yet recruiting

Address

The first hospital of Jilin University

Changchun 2038180, Jilin 2036500, 130000

Dalian 1814087, Liaoning 2036115, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Dalian Medical University

Dalian 1814087, Liaoning 2036115, 116000

Liaoning Cancer Hospital & Institute, Shenyang 2034937, Liaoning 2036115, China

Status

Not yet recruiting

Address

Liaoning Cancer Hospital & Institute

Shenyang 2034937, Liaoning 2036115, 116000

Xi'an 1790630, Shaanxi 1796480, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an 1790630, Shaanxi 1796480, 710000

Jinan 1805753, Shandong 1796328, China

Status

Not yet recruiting

Address

The Affiliated Cancer Hospital of Shandong First Medical University

Jinan 1805753, Shandong 1796328, 250000

Weifang People's Hospital, Weifang 1791681, Shandong 1796328, China

Status

Recruiting

Address

Weifang People's Hospital

Weifang 1791681, Shandong 1796328, 261000

Fudan University Shanghai Cancer Center, Shanghai 1796236, Shanghai Municipality 1796231, China

Status

Recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai 1796236, Shanghai Municipality 1796231, 200000

Shanxi Bethune Hospital, Taiyuan 1793511, Shanxi 1795912, China

Status

Not yet recruiting

Address

Shanxi Bethune Hospital

Taiyuan 1793511, Shanxi 1795912, 030000

Chengdu 1815286, Sichuan 1794299, China

Status

Recruiting

Address

West China Hospital of Sichuan University

Chengdu 1815286, Sichuan 1794299, 610000

Tianjin 1792947, Tianjin Municipality 1792943, China

Status

Not yet recruiting

Address

Tianjin Medical University Cancer Institute & Hospital

Tianjin 1792947, Tianjin Municipality 1792943, 300000

Ürümqi 1529102, Xinjiang 1529047, China

Status

Not yet recruiting

Address

The Affiliated Cancer Hospital, Xinjiang Medical University

Ürümqi 1529102, Xinjiang 1529047, 830000

Yunnan Cancer Hospital, Kunming 1804651, Yunnan 1785694, China

Status

Not yet recruiting

Address

Yunnan Cancer Hospital

Kunming 1804651, Yunnan 1785694, 650000

Hangzhou 1808926, Zhejiang 1784764, China

Status

Recruiting

Address

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

Hangzhou 1808926, Zhejiang 1784764, 310000

Sir Run Run Shaw Hospital, Hangzhou 1808926, Zhejiang 1784764, China

Status

Not yet recruiting

Address

Sir Run Run Shaw Hospital

Hangzhou 1808926, Zhejiang 1784764, 310000

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