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

May 8, 2025 updated by: Bivision Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University First Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China
        • Not yet recruiting
        • Affiliated Hospital of Jiangsu University
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Cancer Hospital Airport Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lutetium Lu 177 JH020002 Injection
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicity (DLT) (Phase 1)
Time Frame: Up to 2 years follow up
Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).
Up to 2 years follow up
Maximum Tolerated Dose (MTD) (Phase 1)
Time Frame: Up to 2 years follow up
The maximum tolerated dose is among the explored dose levels.
Up to 2 years follow up
Recommended Phase 2 Dose (RP2D) (Phase 1)
Time Frame: Up to 2 years follow up
To identify the expansion phase dose of Lutetium Lu 177 JH020002 Injection.
Up to 2 years follow up
PSA response rate
Time Frame: Up to 3 years follow up
PSA response rate is the proportion of PSA responders, defined as a participant who has achieved PSA decrease of >= 50% from baseline that is confirmed by a second consecutive PSA measurement >= 4 weeks later. Determination of response status will be based on PCWG3 recommendations.
Up to 3 years follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) (Phase 2)
Time Frame: Up to 2 years follow up
Proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria response for patients with measurable disease at baseline.
Up to 2 years follow up
Radiation Dosimetry
Time Frame: Up to 2 years follow up
Absorbed dose estimated in organs and tumor lesions.
Up to 2 years follow up
Maximum plasma concentration (Cmax)
Time Frame: Up to 2 years follow up
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Up to 2 years follow up
Time to maximum plasma concentration (Tmax)
Time Frame: Up to 2 years follow up
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Up to 2 years follow up
Terminal elimination half-life (t1/2)
Time Frame: Up to 2 years follow up
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Up to 2 years follow up
Total systemic clearance (CL)
Time Frame: Up to 2 years follow up
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Up to 2 years follow up
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)
Time Frame: Up to 2 years follow up
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Up to 2 years follow up
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf)
Time Frame: Up to 2 years follow up
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Up to 2 years follow up
Volume of distribution (Vz) during the terminal phase following intravenous elimination
Time Frame: Up to 2 years follow up
Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.
Up to 2 years follow up
Radiographic Progression-free Survival (rPFS)
Time Frame: Up to 3 years follow up
Radiographic progression free survival (rPFS) is defined as the time of radiographic progression by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST V1.1.
Up to 3 years follow up
Disease control Rate (DCR)
Time Frame: Up to 3 years follow up
Disease control rate (DCR) is defined as the proportion of participants with best overall response of complete response or partial response or Stable disease in soft tissue according to PCWG3 modified RECIST 1.1.
Up to 3 years follow up
Duration of Response (DoR)
Time Frame: Up to 3 years follow up
Duration of response (DOR) is defined as the duration of time between the date of first documented response (CR or PR) in soft tissue as per BIRC and according to PCWG3 modified RECIST 1.1, and the date of first documented progression or death due to any cause.
Up to 3 years follow up
Time to First Subsequent Therapy (TFST)
Time Frame: Up to 3 years follow up
Time to First Subsequent Therapy (TFST) is defined as the time from the date of first administration of investigational drug to the date of the first subsequent therapy of the prostate cancer.
Up to 3 years follow up
Overall Survival (OS)
Time Frame: Up to 3 years follow up
Overall survival (OS) is defined as the time from the date of first administration of investigational drug to the date of death due to any cause.
Up to 3 years follow up
Time to Symptomatic Skeletal Event (TTSSE)
Time Frame: Up to 3 years follow up
Time to a first symptomatic skeletal event (TTSSE) is defined as date of first administration of investigational drug to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first.
Up to 3 years follow up
Incidence and severity of Adverse Events (AEs) and Serious Adverse Event (SAEs)
Time Frame: Up to 3 years follow up
Analysis of frequencies and severity for Adverse Events (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.
Up to 3 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bivision Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bivision Pharmaceuticals, Inc., Bivision Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JH020002-01C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Bivision Pharmaceuticals, Inc. is committed to sharing with qualified external researchers access to patient-level data. These sharing requests are reviewed and approved by Bivision Pharmaceuticals, Inc subject to certain criteria and conditions. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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