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64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing mCRPC (SECuRE)

Trials in Progress
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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

  • Condition: Prostatic Neoplasms, Castration-Resistant
  • Study ID: NCT04868604
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Publications
Articles and Abstracts
  • A complete response, based on Response Evaluation Criteria In Solid Tumours (RECIST v1.1) assessment, has been reported from the first patient with metastatic castrate-resistant prostate cancer (mCRPC) to ever receive two cycles of Clarity’s 67Cu-SAR-bisPSMA at the 8GBq dose level.

  • First participant in cohort 4 (first multi-dose cohort) in the theranostic SECuRE trial has been treated with 67Cu-SAR-bisPSMA at 12GBq.
  • The SECuRE trial is investigating 64Cu/67Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) patients. Fifteen patients have been treated so far at 3 different dose levels of 67Cu-SAR-bisPSMA (single cycle): 4, 8 and 12GBq.

  • Cohort 3 of the theranostic SECuRE trial investigating 64Cu/67Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has been completed in 6 participants who received therapy with 67Cu-SAR-bisPSMA at the highest single dose level of 12GBq.
  • Undetectable levels of Prostate Specific Antigen (PSA) have been reported from the first patient with metastatic castrate-resistant prostate cancer (mCRPC) to ever receive two cycles of Clarity’s 67Cu-SAR-bisPSMA at the 8GBq dose level. PSA is a marker of tumour burden, clinical response to treatment and an indicator of the recurrence of disease for prostate cancer.
  • Cohort 3 of the theranostic SECuRE trial investigating 64Cu/67Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has enrolled and treated 3 participants who received therapy with 67Cu-SAR-bisPSMA at the highest dose level of 12GBq.­

  • First participant of cohort 3 in the theranostic SECuRE trial investigating 64Cu/67Cu SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has been treated at the highest dose level of 12GBq.
  • Cohort 2 was recently completed in 3 participants who received therapy with 67Cu SAR-bisPSMA at the dose level of 8GBq.
  • Clarity Pharmaceuticals completes recruitment for the initial dosimetry phase of its SAR-bisPSMA theranostic clinical trial SECuRE (NCT04868604)1 investigating Targeted Copper Theranostics (TCT) in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Geoffrey Johnson, MD, PhD,
Dr. Geoffrey Johnson presented SECuRE, a dose escalation/expansion study assessing the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Presented by Geoffrey Johnson, MD, PhD
During the 2024 ASCO GU cancers symposium, Dr. Geoffrey Johnson presented the study framework of SECuRE, a dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate-resistant prostate cancer (mCRPC).