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

Inclusion Criteria6

  • 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 Criteria8

  • 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.

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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