Actively Recruiting
OH2 Injection in Melanoma
Led by Binhui Biopharmaceutical Co., Ltd. · Updated on 2025-07-25
340
Participants Needed
30
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
OH2 Injection in Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older, any gender
- Diagnosed with stage III or IV melanoma by pathology or cytology
- Have failed at least second-line standard therapy including chemotherapy, immunotherapy, or targeted therapy
- Mucosal melanoma cases limited to 22% or fewer of participants
- ECOG physical condition score of 0 to 1
- Expected survival time longer than 3 months
- At least 4 weeks since last antitumor therapy or 2 weeks since bone radiotherapy or 6 weeks since certain chemotherapy, and recovered from side effects except hair loss
- At least 4 weeks after major surgery
- At least one measurable tumor lesion suitable for intratumoral injection meeting RECIST 1.1 criteria
- Stable asymptomatic or treated brain metastases with no progression for at least 3 months and no steroid use for at least 4 weeks
- No severe dysfunction of major organs, meeting specific blood and liver function lab criteria
- Female participants of childbearing potential must test negative for pregnancy before first treatment
- Effective contraception required during and for 3 months after treatment for women and men with partners of reproductive age
- For those with genital herpes, must be at least 3 months after herpes episode
- Voluntary informed consent and expected good compliance
You will not qualify if you...
- Severe uncontrolled medical conditions such as diabetes, infections, or digestive ulcers
- Serious cardiovascular or cerebrovascular diseases including severe heart disease, recent heart attack, or uncontrolled hypertension
- History of primary uveal melanoma or other cancers within 5 years, except certain early-stage skin or cervical cancers
- Symptomatic large pleural effusion or ascites
- Active bone metastases or clinical bone marrow suppression, except stable controlled lesions
- Active autoimmune diseases requiring systemic treatment in past 2 years
- History of immunodeficiency or organ transplantation
- Active hepatitis B or C infections not controlled or negative by required tests
- Active tuberculosis or other infections needing systemic treatment
- History of psychotropic substance abuse, alcoholism, or drug use
- Use of other investigational or antiviral treatments within 4 weeks prior to treatment, except specific hepatitis B drugs
- Received live attenuated vaccine within 4 weeks prior to initial treatment
- Pregnant or breastfeeding women
- Investigator's judgment of ineligibility for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
2
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
Not Yet Recruiting
3
Fujian Cancer Hosptial
Fuzhou, Fujian, China, 350000
Actively Recruiting
4
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
5
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
6
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530000
Not Yet Recruiting
7
Hainan Cancer Hospital
Haikou, Hainan, China, 570100
Not Yet Recruiting
8
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
9
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
10
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450000
Actively Recruiting
11
Hubei Cancer Hospital
Wuhan, Hubei, China, 430000
Not Yet Recruiting
12
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
13
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
14
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
15
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
16
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
17
The first hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
18
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116000
Not Yet Recruiting
19
Liaoning Cancer Hospital ＆ Institute
Shenyang, Liaoning, China, 116000
Not Yet Recruiting
20
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
21
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250000
Not Yet Recruiting
22
Weifang People's Hospital
Weifang, Shandong, China, 261000
Actively Recruiting
23
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
24
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
25
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
26
Tianjin Medical University Cancer Institute ＆ Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
27
The Affiliated Cancer Hospital, Xinjiang Medical University
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
28
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650000
Not Yet Recruiting
29
Cancer Hospital Of The University Of Chinese Academy Of Sciences Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
30
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
Research Team
W
Wentao Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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