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

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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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Articles and Abstracts
Cohort 4 – SECuRE Trial

  • The third participant of cohort 4 (multi-dose) of the SECuRE trial1 has now completed the Dose Limiting Toxicity (DLT) period after a second dose of 12GBq of 67Cu-SAR-bisPSMA, following on from the announcement dated 12 September 2024.2
  • The patient is a 93-year-old with a history of prostate cancer of over 26 years who previously failed multiple lines of therapy. No DLTs were reported after 2 doses of 12GBq of 67Cu-SAR-bisPSMA. The only adverse event (AE) the patient experienced was moderate nausea after the first dose, which resolved.
  • Cohort 4 of the SECuRE trial is the first to assess multiple cycles of 67Cu-SAR-bisPSMA at the highest dose of 12GBq.
  • The Safety Review Committee (SRC) assessed early data from the first 3 participants in cohort 4 who received 2 doses of 67Cu-SAR-bisPSMA. Two of these participants had completed the dose limiting toxicity (DLT) period and 1 will complete the DLT period by the end of September. No DLTs were observed to date, in line with cohorts 1, 2 and 3.
  • The safety profile of multiple doses of 67Cu-SAR-bisPSMA remains positive, with almost all adverse events (AEs) being mild or moderate. Furthermore, almost all AEs have either resolved or improved at the last assessment.
  • Preliminary efficacy assessment from cohort 4 after 2 therapy cycles in 2 participants following completion of the DLT period showed that both participants exhibited greater than 60% drops in prostate-specific antigen (PSA) levels in weeks following their second dose.
  • The SRC recommended, based on this early data, the SECuRE trial proceeds to enroll the last 3 participants of cohort 4, after which Phase II of the study will commence (cohort expansion phase, with 14 patients), pending safety evaluation.
  • Clarity will host a webcast and conference call for shareholders on Wednesday 18 September, details below.
  • 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).