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NCT Number: NCT06139575

Phase 1/2 Clinical Study 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lutetium Lu 177 JH020002 Injection

Drug

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)

Primary outcomes

  1. 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).

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

    Time frame: Up to 2 years follow up

    The maximum tolerated dose is among the explored dose levels.

  3. 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.

  4. 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.

Secondary outcomes

  1. Radiation Dosimetry

    Time frame: Up to 2 years follow up

    Absorbed dose estimated in organs and tumor lesions.

  2. Maximum plasma concentration (Cmax)

    Time frame: Up to 2 years follow up

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

  3. Time to maximum plasma concentration (Tmax)

    Time frame: Up to 2 years follow up

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

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

    Time frame: Up to 2 years follow up

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

  5. Total systemic clearance (CL)

    Time frame: Up to 2 years follow up

    Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bivision Pharmaceuticals, Inc.

CONTACT

[email protected]

86-21-50886996

Sponsors and collaborators

Lead sponsor

Bivision Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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