RecruitingPhase 1Phase 2NCT06139575

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

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


Sponsor

Bivision Pharmaceuticals, Inc.

Enrollment

90 participants

Start Date

Dec 22, 2023

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2 study tests a new targeted radiation therapy drug called Lutetium Lu 177 JH020002 in men with advanced prostate cancer. The drug delivers radiation directly to prostate cancer cells throughout the body, potentially treating cancer that has spread. **You may be eligible if...** - You are male and 18 or older - You have a confirmed diagnosis of prostate adenocarcinoma - Your testosterone is at castrate levels (less than 50 ng/dL) — meaning you are on hormone therapy or surgically castrated - Your overall health is good (ECOG 0–2) - Your life expectancy is more than 6 months - You meet blood count and organ function requirements **You may NOT be eligible if...** - You have neuroendocrine or small cell prostate cancer features - You have had another cancer (with some exceptions for treated skin cancers) - You do not meet the performance status or organ function requirements - Your testosterone is not at castrate levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLutetium 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)


Locations(13)

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

View Full Details on ClinicalTrials.gov

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NCT06139575


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