Clinical Trial · NCT07236112

Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer

Overview

TRDC002 uses a radioactive form (64Cu) to trace the PSMA positive prostate cancer. The purpose of this study is to investigate TRDC002 as a PSMA PET tracer to localize PSMA positive lesions in adult patients with recurrent or metastatic prostate cancer. We plan to assess the PSMA PET/CT image quality following administration of two dose levels of TRDC002 to determine an acceptable dose and optimal acquisition time for obtaining diagnostic quality PET/CT images. The safety and tolerability, PK, biodistribution, dosimetry of TRDC002 will also be evaluated in this study.

Sponsor

TerSera Therapeutics

Phase

Phase 1

Contacts

Yan Wu, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT07236112

Drug / Compound

TRDC002

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

TRDC002

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

Participants with an ECOG performance status of 0 or 1.
Participants must have adequate bone marrow and organ function.
Participants with recurrence or metastasis of prostate cancer.
Participants with PSMA-positive lesions.

Exclusion

A superscan is observed in the baseline bone scan.
Any immunotherapy or biological therapy (including antibodies) targeting PSMA within 60 days prior to the day of randomization.
Participants with symptomatic brain metastases, meningeal metastases, or spinal cord compression.
Concurrent serious (as determined by the Investigator) medical conditions