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)
Study 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
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose Limiting Toxicity (DLT) (Phase 1) — Up to 2 years follow up Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).
Maximum Tolerated Dose (MTD) (Phase 1) — Up to 2 years follow up The maximum tolerated dose is among the explored dose levels.
Recommended Phase 2 Dose (RP2D) (Phase 1) — Up to 2 years follow up To identify the expansion phase dose of Lutetium Lu 177 JH020002 Injection.
PSA response rate — 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.
Trial sites (13)
Facility
City
Region
Status
Anhui Provincial Hospital
Hefei
Anhui
Recruiting
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Not Yet Recruiting
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Wuhan
Hubei
Recruiting
The First Affiliated Hospital of Soochow University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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