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Clinical Trials in China / NCT06139575
Recruiting Phase 1/2

Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer

NCT06139575 · tracked via the Priya Life Science China tracker
Sponsor
Bivision Pharmaceuticals, Inc.
Phase
Phase 1/2
Started
2023-12-22
Last updated
2025-05-13

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

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)

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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. * 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.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui Recruiting
Peking University First Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Recruiting
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Recruiting
Henan Cancer Hospital Zhengzhou Henan Not Yet Recruiting
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital Wuhan Hubei Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Affiliated Hospital of Jiangsu University Wuxi Jiangsu Not Yet Recruiting
Shandong Cancer Hospital Jinan Shandong Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
Tianjin Cancer Hospital Airport Hospital Tianjin Tianjin Municipality Recruiting
Zhejiang Provincial People's Hospital Hangzhou Zhejiang Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06139575 on ClinicalTrials.gov ↗ ← All trials in China