Metastatic Castration-resistant Prostate Cancer, MCRPCPhase 1/2NCT06827080
Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer
A Phase 1/2 study testing 30 mCi NYMO32, 50 mCi NYMO32 and 80 mCi NYMO32 in people with Metastatic Castration-resistant Prostate Cancer, MCRPC and Cancer, run by Zhengguo Chen.
Trial summary
161Tb-NYM032 is a radiopharmaceutical labeled with a PSMA ligand, used for the treatment of metastatic castration-resistant prostate cancer, which is needed for clinical trial to be conducted. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer, MCRPC, Cancer
- What is being tested?
- 30 mCi NYMO32, 50 mCi NYMO32 and 80 mCi NYMO32
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2025to 1 Dec 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
- Inclusion Criteria
- The participant voluntarily signs the informed consent form and is able to complete the trial according to the protocol requirements.
- Male, aged 18 years or older.
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) as per PCWG3 criteria.
- Positive results on 68Ga-NYM032 positron emission tomography (PET)/computed tomography (CT) scan.
- Must have received at least one NAAD treatment (e.g., enzalutamide and/or abiraterone) or at least one taxane-based treatment regimen, or be intolerant to or refuse taxane therapy for metastatic castration-resistant prostate cancer.
- ECOG performance status of 0-2.
- Expected survival of ≥6 months.
- Laboratory parameters must meet the following:
- ALT and AST must not exceed 3 times the upper limit of normal (ULN); BUN and Cr must not exceed 1.5 times the ULN.
- Blood counts: WBC ≥3.5×10^9/L, PLT ≥100×10^9/L, Hb ≥90 g/L.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
161Tb-NYM032 is a radiopharmaceutical labeled with a PSMA ligand, used for the treatment of metastatic castration-resistant prostate cancer, which is needed for clinical trial to be conducted.
- Being tested
- 30 mCi NYMO32, 50 mCi NYMO32, 80 mCi NYMO32, 130 mCi NYMO32, 200 mCi NYMO32
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 mCi NYMO32Drug
The initial dose is set at 30 mCi.
50 mCi NYMO32Drug
The dose will be escalated to 50 mCi.
80 mCi NYMO32Drug
The dose will be escalated to 80 mCi.
130 mCi NYMO32Drug
The dose will be escalated to 130 mCi.
200 mCi NYMO32Drug
The maximum dose is set at 200 mCi.
| Study group | Role | What they receive |
|---|---|---|
| 161Tb-NY032 | Experimental | Not described Receives: Drug: 30 mCi NYMO32; Drug: 50 mCi NYMO32; Drug: 80 mCi NYMO32; Drug: 130 mCi NYMO32; Drug: 200 mCi NYMO32 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA
PSA levels can be used to monitor the treatment efficacy, disease progression, or recurrence of prostate cancer. A decrease in PSA levels after treatment usually indicates effective therapy, while an increase in PSA levels may suggest disease recurrence or progression.
Measured: 5-6 weeks after each administration.
68Ga-NYM032 PET/CT
Reflect the PSMA expression level in the patient's lesions.
Measured: **5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.**
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start11 Feb 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer, MCRPCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengguo Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhengguo Chen, Mianyang Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827080
- Sponsor's protocol ID
- MianyangNC
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06827080
- Acronym / sponsor ID
- MianyangNC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Zhengguo ChenUniversity, hospital or other
- Study start
- 11 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
161Tb-NYM032 is a radiopharmaceutical labeled with a PSMA ligand, used for the treatment of metastatic castration-resistant prostate cancer, which is needed for clinical trial to be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 161Tb-NY032 | Experimental | Drug: 30 mCi NYMO32, Drug: 50 mCi NYMO32, Drug: 80 mCi NYMO32, Drug: 130 mCi NYMO32, Drug: 200 mCi NYMO32 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 mCi NYMO32The initial dose is set at 30 mCi. | Drug | 161Tb-NY032 |
| 50 mCi NYMO32The dose will be escalated to 50 mCi. | Drug | 161Tb-NY032 |
| 80 mCi NYMO32The dose will be escalated to 80 mCi. | Drug | 161Tb-NY032 |
| 130 mCi NYMO32The dose will be escalated to 130 mCi. | Drug | 161Tb-NY032 |
| 200 mCi NYMO32The maximum dose is set at 200 mCi. | Drug | 161Tb-NY032 |
Primary outcome
PSA
Time frame: 5-6 weeks after each administration.
PSA levels can be used to monitor the treatment efficacy, disease progression, or recurrence of prostate cancer. A decrease in PSA levels after treatment usually indicates effective therapy, while an increase in PSA levels may suggest disease recurrence or progression.
68Ga-NYM032 PET/CT
Time frame: **5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.**
Reflect the PSMA expression level in the patient's lesions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Castration-resistant Prostate Cancer, MCRPC
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 30 mCi NYMO32, 50 mCi NYMO32 and 80 mCi NYMO32 in people with Metastatic Castration-resistant Prostate Cancer, MCRPC and Cancer, run by Zhengguo Chen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact ZhengGuo Chen ZGC ZhengGuo Chen (0816-2226753, 86753979@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA (time frame: 5-6 weeks after each administration.). 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?
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 14 Feb 2025.