Tests lutetium Lu 177 JH020002 injection for advanced prostate cancer
Tests a radioactive lutetium injection in adults with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
Key facts
- Where
- Beijing, Chengdu, Fuzhou, Guangzhou, Hangzhou, Hefei, Jinan, Shanghai, Suzhou, Tianjin, Wuhan, Wuxi, and Zhengzhou, ChinaSee the 13 sites
- Phase
- Phase 1/2
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaTaking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
- Zhejiang Provincial People's HospitalHangzhou, ChinaTaking people
- Anhui Provincial HospitalHefei, ChinaTaking people
- Shandong Cancer HospitalJinan, ChinaTaking people
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Tianjin Cancer Hospital Airport HospitalTianjin, ChinaTaking people
- Huazhong University of Science and Technology Tongji Medical College Affiliated Union HospitalWuhan, ChinaTaking people
- Affiliated Hospital of Jiangsu UniversityWuxi, ChinaNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bivision Pharmaceuticals, Inc.
- Trial code
- NCT06139575
- Record updated
- 9 October 2026
- Original description
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.Read full original descriptionShow less
Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Preliminary Efficacy of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
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.
Inclusion: Subjects are required to get informed consent prior to the trial and sign a written informed consent form voluntarily; Male, age ≥18 years; ECOG score 0 - 2; Must have a life expectancy >6 months; Histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features); Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dl, or < 1.7nmol/L).
Exclusion: Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity; Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation <6 months prior to date of first administration of investigational drug; Previous PSMA-targeted radioligand therapy; Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug; Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological therapy within 4 weeks prior to date of first administration of investigational drug; Must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug; Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician; History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.