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Trial Title:
A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC
NCT ID:
NCT06383052
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-NYM032 injection
Description:
Radionuclide 177Lu will be used as a therapeutic nuclide for this study. The precursor of
NYM032 will be labeled with 177Lu to form the chelation product, 177Lu-NYM032 injection
which will be used in this study as a intravenous injection dose of 177Lu-NYM032. The
radiation dose is chosen within the range of 50-200 mCi for an individual patient at
every dose.
Arm group label:
177Lu-NYM032 injection
Summary:
177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific
membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with
strong affinity for PSMA.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years;
2. Histologically or cytologically confirmed adenocarcinoma of prostate；
3. Documented progressive metastatic CRPC based on Prostate Cancer Working Group
3(PCWG3) criteria, which includes at least one of the following criteria: a.PSA
progression;b.Objective radiographic progression in soft tissue; c.New bone lesions
4. Have serum testosterone < 50 ng/dL;
5. Patients with significant PSMA avidity on 68Ga-NYM032 PET/CT；
6. ECOG score of 0 or 1；
7. Expected life≥ 6 months;
8. Patients must have received at least one NAAD；
9. Patients must have received taxane-based chemotherapy or not be candidates for
taxane chemotherapy；
10. Patients must have adequate organ and marrow function；
11. The subjects agree to take effective contraceptive measures during the study period
and for at least three months after the drug administration:
12. The subjects are able to maintain good communication with the researchers,
understand and follow the requirements of this study, voluntarily participate, and
sign an informed consent form before the start of relevant research operations.
Exclusion Criteria:
1. Previous treatment with any of the following within 6 months before enrollment:
Strontium-89,Samarium-153,Rhenium-186,Rhenium-188, Radium-223,hemi-body irradiation.
Previous PSMA-targeted radioligand therapy is not allowed;
2. Any systemic anti-cancer therapy(e.g.chemotherapy, immunotherapy or biological
therapy [including monoclonal antibodies]) within 28 days prior to day of
enrollment;
3. Site(s) of disease that are FDG positive with minimal PSMA expression ;
4. Any investigational agents within 28 days prior to day of enrollment;
5. Known hypersensitivity to the components of the 177Lu-NYM032 or its analogs;
6. Other concurrent investigational therapy;
7. Transfusion for the sole purpose of making a subject eligible for study inclusion;
8. Patients with a history of Central Nervous System (CNS) metastases must have
received therapy (surgery, radiotherapy, gamma knife) and be neurologically
stable,asymptomatic, and not receiving corticosteroids for the purposes of
maintaining neurologic integrity, Patients with epidural disease, canal disease and
prior cord involvement are eligible if those areas have been treated, are stable,
and not neurologically impaired. For patients with parenchymal CNS metastasis (or a
history of CNS metastasis), baseline and subsequent radiological imaging must
include evaluation of the brain (MRI preferred or CT with contrast);
9. A superscan as seen in the baseline bone scan;
10. Symptomatic cord compression, or clinical or radiologic findings indicative of
impending cord compression;
11. Concurrent serious (as determined by the Principal Investigator) medical conditions
that in the opinion of the investigator would impair study participation or
cooperation;
12. Diagnosed with other malignancies that are expected to alter life expectancy or may
interfere with disease assessment. However, patients with a prior history of
malignancy that has been adequately treated and who have been disease free for more
than 3 years are eligible, as are patients with adequately treated non-melanoma skin
cancer, superficial bladder cancer;
13. Eligible for treatment(s) other than ARDT based on the presence of any mutations or
biomarkers that are known as predictors of better response (e.g., AR-V7 or BRCA).
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Affliated Hospital of Jiangnan University
Address:
City:
Wuxi
Zip:
214000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunjing Yu
Phone:
15312238622
Email:
ycj_wxd1978@163.com
Start date:
April 30, 2024
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Norroy Bioscience Co., LTD
Agency class:
Industry
Source:
Norroy Bioscience Co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383052
