XCancer

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

Description:

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)

Government Study Link:

NCT07236112 - Click here to see study on

ClinicalTrials.gov

TRDC002

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

TRDC002

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
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