Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
NCT ID: NCT06139575
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2023-12-22
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Lutetium Lu 177 JH020002 Injection
Lutetium Lu 177 JH020002 Injection
Patients will receive Lutetium Lu 177 JH020002 Injection every 6 weeks for a maximum of 6 doses. Doses range between 1.85 and 8.88 GBq (50-240 mCi)
Interventions
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Lutetium Lu 177 JH020002 Injection
Patients will receive Lutetium Lu 177 JH020002 Injection every 6 weeks for a maximum of 6 doses. Doses range between 1.85 and 8.88 GBq (50-240 mCi)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
18 Years
MALE
No
Sponsors
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Bivision Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bivision Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Bivision Pharmaceuticals, Inc.
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Wuxi, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JH020002-01C
Identifier Type: -
Identifier Source: org_study_id
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