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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
Highlights

  • Another participant with metastatic castration-resistant prostate cancer (mCRPC) in the Cohort Expansion Phase (Phase II; 8 GBq of 67Cu-SAR-bisPSMA per cycle) of the SECuRE trial (NCT04868604)1 achieved undetectable disease as assessed by prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA) positron emission tomography (PET).
  • Undetectable disease by PSA was achieved after the first cycle, followed by a negative PSMA PET after the second cycle of 67Cu-SAR-bisPSMA.
  • Clarity has successfully completed a $203 million Placement with a small group of institutional investors who are close to the Company.
  • The issue price of the Placement is $4.20 per share, which represents a 2.2% premium to Clarity’s previous closing price and an 18.0% premium to Clarity’s 15-day Volume Weighted Average Price (“VWAP”).
  • Following completion of the Placement, the pro-forma cash balance of the Company is approximately $288 million,1 providing Clarity with an enviable Balance Sheet. This will help fund the below-mentioned expected catalysts and milestones, including the completion of a number of high-value pivotal clinical trials and advancement of key milestones in its therapeutic and diagnostic pipeline.

  • The first of the planned 24 participants in the Cohort Expansion Phase (Phase II) of the SECuRE trial has been treated with their first dose of 8 GBq of 67Cu-SAR-bisPSMA.This follows the recent recommendation by the Safety Review Committee (SRC) after the successful completion of the Dose Escalation Phase to commence enrollment for the Cohort Expansion Phase at the 8 GBq dose level, with an increase of the number of cycles from up to 4 to up to 6.
  • This participant will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), as per the recent protocol amendment to include a subset of participants in the Cohort Expansion Phase to receive this combination.
Reno, Nevada (UroToday.com) -- Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the United States (US) Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 67Cu-SAR-bisPSMA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition (ARPI).
  • Nucleus RadioPharma will manufacture the 67Cu-SAR-bisPSMA drug product at their new state-of-the-art facility in Rochester, MN.
  • The Master Services Agreement (MSA) and Clinical Supply Agreement with Nucleus RadioPharma complement the existing agreement with NorthStar Medical Radioisotopes, LLC (NorthStar) for 67Cu-SAR-bisPSMA production to expand drug manufacturing in anticipation of recruitment demand for Phase II and III trials of this product.
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.
  • 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 Scientists
Presented by Geoffrey B. Johnson, MD, PhD
Geoffrey B. Johnson, MD, PhD, discussing 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).
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).