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
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