Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer

Zhengguo Chen

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Metastatic Castration-resistant Prostate Cancer, MCRPC; Cancer

Treatments: Drug: 50 mCi NYMO32; Drug: 30 mCi NYMO32; Drug: 80 mCi NYMO32; Drug: 130 mCi NYMO32; Drug: 200 mCi NYMO32

Study type: Interventional

Funder types: Other

Identifiers

NCT06827080

MianyangNC

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

**1. Inclusion Criteria**

1. The participant voluntarily signs the informed consent form and is able to complete the trial according to the protocol requirements.

2. Male, aged 18 years or older.

3. Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) as per PCWG3 criteria.

4. Positive results on 68Ga-NYM032 positron emission tomography (PET)/computed tomography (CT) scan.

5. 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.

6. ECOG performance status of 0-2.

7. Expected survival of ≥6 months.

8. Laboratory parameters must meet the following:

   1. 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.
   2. Blood counts: WBC ≥3.5×10^9/L, PLT ≥100×10^9/L, Hb ≥90 g/L.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

161Tb-NY032

Experimental group

Treatment:

Drug: 200 mCi NYMO32

Drug: 130 mCi NYMO32

Drug: 80 mCi NYMO32

Drug: 30 mCi NYMO32

Drug: 50 mCi NYMO32