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

ConditionsMetastatic Castration-resistant Prostate Cancer, MCRPCCancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorZhengguo Chen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 30 mCi NYMO32

    Drug

    The initial dose is set at 30 mCi.

  • 50 mCi NYMO32

    Drug

    The dose will be escalated to 50 mCi.

  • 80 mCi NYMO32

    Drug

    The dose will be escalated to 80 mCi.

  • 130 mCi NYMO32

    Drug

    The dose will be escalated to 130 mCi.

  • 200 mCi NYMO32

    Drug

    The maximum dose is set at 200 mCi.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: 161Tb-NY032Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
5-6 weeks after each administration.
2

68Ga-NYM032 PET/CT

\*\*Reflect the PSMA expression level in the patient's lesions.\*\*

Time frame
**5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.**

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhengguo Chen

Lead sponsor

Mianyang Central Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: