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Recruiting NCT06139575

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

Phase I / Phase II Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lutetium Lu 177 JH020002 Injection.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Dose Limiting Toxicity (DLT) (Phase 1) [Time frame: Up to 2 years follow up]
  • Maximum Tolerated Dose (MTD) (Phase 1) [Time frame: Up to 2 years follow up]
  • Recommended Phase 2 Dose (RP2D) (Phase 1) [Time frame: Up to 2 years follow up]
  • PSA response rate [Time frame: Up to 3 years follow up]
Secondary outcome measures (12)
  • Radiation Dosimetry [Time frame: Up to 2 years follow up]
  • Maximum plasma concentration (Cmax) [Time frame: Up to 2 years follow up]
  • Time to maximum plasma concentration (Tmax) [Time frame: Up to 2 years follow up]
  • Terminal elimination half-life (t1/2) [Time frame: Up to 2 years follow up]
  • Total systemic clearance (CL) [Time frame: 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]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf) [Time frame: 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]
  • Radiographic Progression-free Survival (rPFS) [Time frame: Up to 3 years follow up]
  • Disease control Rate (DCR) [Time frame: Up to 3 years follow up]
  • Duration of Response (DoR) [Time frame: Up to 3 years follow up]
  • Time to First Subsequent Therapy (TFST) [Time frame: Up to 3 years follow up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 13 centers
  • Anhui Provincial Hospital — Hefei
  • Peking University First Hospital — Beijing
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou
  • Sun Yat-Sen University Cancer Center — Guangzhou
  • Henan Cancer Hospital — Zhengzhou
  • Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hosp — Wuhan
  • The First Affiliated Hospital of Soochow University — Suzhou
  • Affiliated Hospital of Jiangsu University — Wuxi
  • … and 5 more centers

Identifiers

NCT: NCT06139575 · JH020002-01C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗