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Trial Title:
Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer
NCT ID:
NCT06139575
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lutetium Lu 177 JH020002 Injection
Description:
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)
Arm group label:
Lutetium Lu 177 JH020002 Injection
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Dingwei Ye, M.D.
Phone:
+8613701663571
Email:
fuscc2012@163.com
Contact backup:
Last name:
Shaoli Song, M.D.
Phone:
+8613816608573
Email:
shaoli-song@163.com
Start date:
December 22, 2023
Completion date:
July 2027
Lead sponsor:
Agency:
Bivision Pharmaceuticals, Inc.
Agency class:
Industry
Source:
Bivision Pharmaceuticals, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139575
