XCancer
Clarity Pharmaceuticals

A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer

Description:

The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Sponsor:

Clarity Pharmaceuticals

Phase:

Phase 1/2

Contacts:

Clarity Pharmaceuticals (Clarity Clinical)

clinicaltrials@claritypharmaceuticals.com

+61 0 2 9209 4037

Government Study Link:

NCT04868604 - Click here to see study on

ClinicalTrials.gov

Inclusion
  • •≥1 metastatic lesion that is present at screening CT, MRI, or bone scan imaging ≤28 days prior to enrolment
  • •Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa)
  • •Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
  • •Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy
  • •Eastern Cooperative Oncology Group performance status of 0 to 2
Exclusion
  • •Spinal metastasis with symptomatic cord compression, or clinical or radiologic indicative findings
  • •Prior history of leukemia or Myelodysplastic Syndrome
  • •Symptomatic Brain metastasis
  • •Histologic diagnosis of small cell or neuroendocrine prostate cancer

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