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Metastatic Castration-resistant Prostate CancerPhase 1/2NCT06383052

A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC

A Phase 1/2 study testing 177Lu-NYM032 injection in people with Metastatic Castration-resistant Prostate Cancer, run by Norroy Bioscience Co., LTD at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
177Lu-NYM032 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
26 Apr 2024to 30 Jun 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years;
  • Histologically or cytologically confirmed adenocarcinoma of prostate；
  • 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
  • Have serum testosterone < 50 ng/dL;
  • Patients with significant PSMA avidity on 68Ga-NYM032 PET/CT；
  • ECOG score of 0 or 1；
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  • Expected life≥ 6 months;
  • Patients must have received at least one NAAD；
  • Patients must have received taxane-based chemotherapy or not be candidates for taxane chemotherapy；
  • Patients must have adequate organ and marrow function；
  • The subjects agree to take effective contraceptive measures during the study period and for at least three months after the drug administration:
  • 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.

Who cannot join

  • 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;
  • Any systemic anti-cancer therapy(e.g.chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of enrollment;
  • Site(s) of disease that are FDG positive with minimal PSMA expression ;
  • Any investigational agents within 28 days prior to day of enrollment;
  • Known hypersensitivity to the components of the 177Lu-NYM032 or its analogs;
  • Other concurrent investigational therapy;
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  • Transfusion for the sole purpose of making a subject eligible for study inclusion;
  • 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);
  • A superscan as seen in the baseline bone scan;
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression;
  • Concurrent serious (as determined by the Principal Investigator) medical conditions that in the opinion of the investigator would impair study participation or cooperation;
  • 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;
  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affliated Hospital of Jiangnan University

    Wuxi, 214000

Other trials in China

About this study

Official title: A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Radiation Dosimetry and Efficacy of 177Lu-NYM032 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

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.

Being tested
177Lu-NYM032 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-NYM032 injectionDrug

    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.

Study groups in NCT06383052
Study groupRoleWhat they receive
177Lu-NYM032 injectionExperimentalNot described
Receives: Drug: 177Lu-NYM032 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Dose Limiting Toxicity (DLT)

    Dose limiting toxicity is determined by monitoring for adverse events following therapy.

    Measured: 28 days

  2. Maximum Tolerated Dose (MTD)

    Maximum tolerated dose (MTD) is determined by monitoring dose-limiting toxicity and adverse events in the dosing cohorts

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start26 Apr 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06383052
Sponsor's protocol ID
CP-2023-04
Other IDs
NYM032Z01
Status last verified
Nov 2024
First submitted
17 Apr 2024
Last updated
21 May 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 177Lu-NYM032 injection in people with Metastatic Castration-resistant Prostate Cancer, run by Norroy Bioscience Co., LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Dose Limiting Toxicity (DLT) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383052.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.

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