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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.
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 |
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 |
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
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
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.
Status
Recruiting
Address
Peking University Cancer Hospital
Beijing 1816670, Beijing Municipality 2038349, 100010
Status
Not yet recruiting
Address
Chongqing University Cancer Hospital
Chongqing 1814906, Chongqing Municipality 1814905, 400000
Status
Recruiting
Address
Fujian Cancer Hosptial
Fuzhou 1810821, Fujian 1811017, 350000
Status
Not yet recruiting
Address
Dermatology Hospital of Southern Medical University
Guangzhou 1809858, Guangdong 1809935, 510000
Status
Not yet recruiting
Address
Sun Yat-sen University Cancer Center
Guangzhou 1809858, Guangdong 1809935, 510000
Status
Not yet recruiting
Address
Guangxi Medical University Cancer Hospital
Nanning 1799869, Guangxi 1809867, 530000
Status
Not yet recruiting
Address
Hainan Cancer Hospital
Haikou 1809078, Hainan 1809054, 570100
Status
Not yet recruiting
Address
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Shijiazhuang 1795270, Hebei 1808773, 050000
Status
Not yet recruiting
Address
The First Affiliated Hospital of Harbin Medical University
Harbin 2037013, Heilongjiang 2036965, 150000
Status
Recruiting
Address
The Third People's Hospital of Zhengzhou
Zhengzhou 1784658, Henan 1808520, 450000
Status
Not yet recruiting
Address
Hubei Cancer Hospital
Wuhan 1791247, Hubei 1806949, 430000
Status
Not yet recruiting
Address
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan 1791247, Hubei 1806949, 430000
Status
Recruiting
Address
Hunan Cancer Hospital
Changsha 1815577, Hunan 1806691, 410000
Status
Recruiting
Address
Nanjing Drum Tower Hospital
Nanjing 1799962, Jiangsu 1806260, 210000
Status
Not yet recruiting
Address
The First Affiliated Hospital of Nanchang University
Nanchang 1800163, Jiangxi 1806222, 330000
Status
Recruiting
Address
Jilin Cancer Hospital
Changchun 2038180, Jilin 2036500, 130000
Status
Not yet recruiting
Address
The first hospital of Jilin University
Changchun 2038180, Jilin 2036500, 130000
Status
Not yet recruiting
Address
The First Affiliated Hospital of Dalian Medical University
Dalian 1814087, Liaoning 2036115, 116000
Status
Not yet recruiting
Address
Liaoning Cancer Hospital & Institute
Shenyang 2034937, Liaoning 2036115, 116000
Status
Not yet recruiting
Address
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an 1790630, Shaanxi 1796480, 710000
Status
Not yet recruiting
Address
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan 1805753, Shandong 1796328, 250000
Status
Recruiting
Address
Weifang People's Hospital
Weifang 1791681, Shandong 1796328, 261000
Status
Recruiting
Address
Fudan University Shanghai Cancer Center
Shanghai 1796236, Shanghai Municipality 1796231, 200000
Status
Not yet recruiting
Address
Shanxi Bethune Hospital
Taiyuan 1793511, Shanxi 1795912, 030000
Status
Recruiting
Address
West China Hospital of Sichuan University
Chengdu 1815286, Sichuan 1794299, 610000
Status
Not yet recruiting
Address
Tianjin Medical University Cancer Institute & Hospital
Tianjin 1792947, Tianjin Municipality 1792943, 300000
Status
Not yet recruiting
Address
The Affiliated Cancer Hospital, Xinjiang Medical University
Ürümqi 1529102, Xinjiang 1529047, 830000
Status
Not yet recruiting
Address
Yunnan Cancer Hospital
Kunming 1804651, Yunnan 1785694, 650000
Status
Recruiting
Address
Cancer Hospital Of The University Of Chinese Academy Of Sciences Zhejiang Cancer Hospital
Hangzhou 1808926, Zhejiang 1784764, 310000
Status
Not yet recruiting
Address
Sir Run Run Shaw Hospital
Hangzhou 1808926, Zhejiang 1784764, 310000