Evaluating Lutetium Lu 177 JH020002 Injection for 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

This study is testing a new injection for advanced prostate cancer to see if it's safe and effective for adult men with the disease.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Bivision Pharmaceuticals, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 13 sites (Hefei, Anhui and 12 other locations)
• Trial ID: NCT06139575 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients diagnosed with advanced prostate cancer. The study will involve male participants aged 18 and older who have a confirmed diagnosis of adenocarcinoma of the prostate and meet specific health criteria. Participants will receive the injection and be monitored for their response and any side effects throughout the trial phases.

Who should consider this trial

Good fit: Ideal candidates include adult males with advanced prostate cancer who have a life expectancy of more than six months and meet the study's health criteria.

Not a fit: Patients with other malignancies or those with a history of central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer.

How similar studies have performed: Other studies using targeted radioligand therapies for prostate cancer have shown promising results, indicating potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 12 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital — Wuhan, Hubei, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Affiliated Hospital of Jiangsu University — Wuxi, Jiangsu, China (Not_yet_recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Bivision Pharmaceuticals, Inc.

Conditions Prostate Cancer