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Prostate CancerPhase 1/2NCT06139575

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

A Phase 1/2 study testing Lutetium Lu 177 JH020002 Injection in people with Prostate Cancer, run by Bivision Pharmaceuticals, Inc. at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Lutetium Lu 177 JH020002 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
13 sitesChina
Study dates
22 Dec 2023to Jul 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bivision Pharmaceuticals, Inc. contact

86-21-50886996

bivision.public1@bivisionpharma.com

13 sites in 1 country

China13 sites, 13 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

    Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Dingwei Ye, M.D., +8613701663571, fuscc2012@163.com

    Shaoli Song, M.D., +8613816608573, shaoli-song@163.com

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality

    Recruiting

  • Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital

    Wuhan, Hubei

    Recruiting

  • Affiliated Hospital of Jiangsu University

    Wuxi, Jiangsu

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Prostate Cancer
Being tested
Lutetium Lu 177 JH020002 Injection
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lutetium Lu 177 JH020002 InjectionDrug

    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 groups in NCT06139575
Study groupRoleWhat they receive
Lutetium Lu 177 JH020002 InjectionExperimentalNot described
Receives: Drug: Lutetium Lu 177 JH020002 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT) (Phase 1)

    Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).

    Measured: Up to 2 years follow up

  2. Maximum Tolerated Dose (MTD) (Phase 1)

    The maximum tolerated dose is among the explored dose levels.

    Measured: Up to 2 years follow up

  3. Recommended Phase 2 Dose (RP2D) (Phase 1)

    To identify the expansion phase dose of Lutetium Lu 177 JH020002 Injection.

    Measured: Up to 2 years follow up

  4. PSA response rate

    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.

    Measured: Up to 3 years follow up

Secondary outcomes (16)

  1. Radiation Dosimetry

    Absorbed dose estimated in organs and tumor lesions.

    Measured: Up to 2 years follow up

  2. Maximum plasma concentration (Cmax)

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

    Measured: Up to 2 years follow up

  3. Time to maximum plasma concentration (Tmax)

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

    Measured: Up to 2 years follow up

  4. Terminal elimination half-life (t1/2)

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

    Measured: Up to 2 years follow up

  5. Total systemic clearance (CL)

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

    Measured: Up to 2 years follow up

  6. Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

    Measured: Up to 2 years follow up

  7. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf)

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

    Measured: Up to 2 years follow up

  8. Volume of distribution (Vz) during the terminal phase following intravenous elimination

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

    Measured: Up to 2 years follow up

  9. Radiographic Progression-free Survival (rPFS)

    Radiographic progression free survival (rPFS) is defined as the time of radiographic progression by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST V1.1.

    Measured: Up to 3 years follow up

  10. Disease control Rate (DCR)

    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.

    Measured: Up to 3 years follow up

  11. Duration of Response (DoR)

    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.

    Measured: Up to 3 years follow up

  12. Time to First Subsequent Therapy (TFST)

    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.

    Measured: Up to 3 years follow up

  13. Overall Survival (OS)

    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.

    Measured: Up to 3 years follow up

  14. Time to Symptomatic Skeletal Event (TTSSE)

    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.

    Measured: Up to 3 years follow up

  15. Incidence and severity of Adverse Events (AEs) and Serious Adverse Event (SAEs)

    Analysis of frequencies and severity for Adverse Events (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: Up to 3 years follow up

  16. Objective Response Rate (ORR) (Phase 2)

    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.

    Measured: Up to 2 years follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start22 Dec 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139575
Sponsor's protocol ID
JH020002-01C
Status last verified
Oct 2026
First submitted
9 Nov 2023
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lutetium Lu 177 JH020002 Injection in people with Prostate Cancer, run by Bivision Pharmaceuticals, Inc. at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bivision Pharmaceuticals, Inc. (86-21-50886996, bivision.public1@bivisionpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (Phase 1) (time frame: Up to 2 years follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06139575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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