Actively Recruiting
Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
Led by Bivision Pharmaceuticals, Inc. · Updated on 2025-05-13
90
Participants Needed
13
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients with advanced prostate cancer.
CONDITIONS
Official Title
Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must provide written informed consent before joining the trial.
- Male participants aged 18 years or older.
- ECOG performance status score between 0 and 2.
- Life expectancy greater than 6 months.
- Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding neuroendocrine or small cell types).
- Castrate serum/plasma testosterone level below 50 ng/dl or 1.7 nmol/L.
You will not qualify if you...
- Diagnosis of other cancers except adequately treated skin basal cell carcinoma or superficial bladder cancers disease-free for more than 3 years.
- History of unstable or symptomatic central nervous system metastases or requiring corticosteroids for neurological stability.
- Treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, or hemi-body irradiation within 6 months before first drug administration.
- Prior PSMA-targeted radioligand therapy.
- Radiotherapy for prostate cancer within 4 weeks prior to first drug administration.
- Systemic anti-cancer therapy (chemotherapy, immunotherapy, PARPi, or biological therapy) within 4 weeks prior to first drug administration.
- Participation in other investigational therapies within 4 weeks prior to first drug administration.
- History of allergic reaction to the study drug, its ingredients, or similar drugs.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
2
Peking University First Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
4
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
6
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Wuhan, Hubei, China
Actively Recruiting
7
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
8
Affiliated Hospital of Jiangsu University
Wuxi, Jiangsu, China
Not Yet Recruiting
9
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
10
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
11
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
12
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
13
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
B
Bivision Pharmaceuticals, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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