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64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) (SECuRE)

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ClinicalTrials.gov Identifier: NCT04868604
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
Clarity Pharmaceuticals Ltd

Tracking Information
First Submitted Date  ICMJE April 15, 2021
First Posted Date  ICMJE May 3, 2021
Last Update Posted Date March 27, 2024
Actual Study Start Date  ICMJE August 11, 2021
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2022)
  • Biodistribution of 64Cu-SAR-bisPSMA [ Time Frame: 48 hours ]
    Biodistribution will be calculated by utilizing the PET/CT scans.
  • Dosimetry of 64Cu-SAR-bisPSMA [ Time Frame: 48 hours ]
    Dosimetry will be calculated by utilizing the PET/CT scans.
  • Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans [ Time Frame: 48 hours ]
    Dosimetry will be calculated by utilizing the PET/CT scans.
  • Maximum Tolerated Dose (MTD) or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA [ Time Frame: 8 weeks ]
    MDT as determined by cohort observations of dose limiting toxicities (DLT)
  • Recommended dose of two doses of 67Cu-SAR-bisPSMA [ Time Frame: 14 weeks ]
    Recommended dose as determined by cohort observations of DLTs
  • Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response [ Time Frame: Up to 5 years ]
    Proportion of participants with ≥50% decline in PSA
  • Efficacy of 67Cu-SAR-bisPSMA in terms of radiographic response [ Time Frame: Up to 5 years ]
    Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according PCWG3 for bone lesions
  • Incidence of 67Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 5 years ]
    Adverse Events will be as assessed by CTCAE version 5.00
  • Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in Vital Signs [ Time Frame: Up to 1 year ]
    Change from baseline in vital signs
  • Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in electrocardiogram (ECG) parameters [ Time Frame: Up to 24 weeks ]
    Change from baseline in ECG parameters
  • Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in laboratory results [ Time Frame: Up to 22 weeks ]
    Change from baseline in laboratory results
  • Incidence of 64Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 5 years ]
    Adverse Events will be as assessed by CTCAE version 5.00
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2021)
  • Biodistribution of 64Cu-SAR-bisPSMA [ Time Frame: 48 hours ]
    Biodistribution will be calculated by utilizing the PET/CT scans.
  • Dosimetry of 64Cu-SAR-bisPSMA [ Time Frame: 48 hours ]
    Dosimetry will be calculated by utilizing the PET/CT scans.
  • Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans [ Time Frame: 48 hours ]
    Dosimetry will be calculated by utilizing the PET/CT scans.
  • Maximum Tolerated Dose or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA [ Time Frame: 8 weeks ]
    MDT as determined by cohort observations of DLTs
  • Recommended dose of two doses of 67Cu-SAR-bisPSMA [ Time Frame: 14 weeks ]
    Recommended dose as determined by cohort observations of DLTs
  • Efficacy of 67Cu-SAR-bisPSMA in terms of PSA response [ Time Frame: Up to 5 years ]
    Proportion of participants with ≥50% decline in PSA
  • Efficacy of 67Cu-SAR-bisPSMA in terms of radiographic response [ Time Frame: Up to 5 years ]
    Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according PCWG3 for bone lesions
  • Incidence of 67Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 5 years ]
    Adverse Events will be as assessed by CTCAE version 5.00
  • Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in Vital Signs [ Time Frame: Up to 1 year ]
    Change from baseline in vital signs
  • Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in ECG parameters [ Time Frame: Up to 24 weeks ]
    Change from baseline in ECG parameters
  • Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in laboratory results [ Time Frame: Up to 22 weeks ]
    Change from baseline in laboratory results
  • Incidence of 64Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 5 years ]
    Adverse Events will be as assessed by CTCAE version 5.00
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This study is to be conducted in 3 phases, a dosimetry phase, a dose escalation phase and a cohort expansion phase.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms, Castration-Resistant
Intervention  ICMJE
  • Drug: 64Cu-SAR-bisPSMA
    64Cu-SAR-bisPSMA
  • Drug: 67Cu-SAR-bisPSMA
    67Cu-SAR-bisPSMA
Study Arms  ICMJE Experimental: 67Cu-SAR-bisPSMA

In the dosimetry phase patients will receive a single 200 MBq administration of 64Cu-SAR-bisPSMA.

In the dose escalation phase patients will receive up to 2 administrations of 200 MBq of 64Cu-SAR-bisPSMA.

In the cohort expansion phase patients will receive up to 3 administrations of 200 MBq of 64Cu-SAR-bisPSMA.

In the dose escalation phase patients will receive up to 2 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation).

In the cohort expansion phase patients will receive 2 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation.

Interventions:
  • Drug: 64Cu-SAR-bisPSMA
  • Drug: 67Cu-SAR-bisPSMA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2021)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2026
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent;
  • ≥18 years of age;
  • Eastern Cooperative Oncology Group performance status of 0 to 2;
  • Life expectancy >6 months;
  • Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa);
  • Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value [SUV] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan;
  • 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 and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria:

    1. Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;
    2. Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;
    3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.
  • ≥1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment into the study;
  • Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.);
  • Participants must have adequate organ function:

    • Bone marrow reserve:

      • White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR
      • Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1.5 x 109 /L is equivalent to 1.5 x 103 /μL and 1.5 x K/μL and 1.5 x 103 /cc and 1500/μL);
    • Platelets ≥100 x 109 /L (100 x 109 /L is equivalent to 100 x 103 /μL and 100 x K/μL and 100 x 103 /cc and 100,000/μL);
    • Hemoglobin ≥9 g/dL (5.59 mmol/L);
    • Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;
    • Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases;
    • Creatinine clearance or estimated glomerular filtration rate ≥50 mL/min
  • For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;
  • For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

Exclusion Criteria:

  • Major surgery within 12 weeks prior to enrollment into the study;
  • Brain metastasis;
  • Histologic diagnosis of small cell or neuroendocrine prostate cancer;
  • Prior history of leukemia or Myelodysplastic Syndrome;
  • Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;
  • Unmanageable urinary tract obstruction;
  • Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is prostate-specific membrane antigen (PSMA) negative on the 1 hour 64Cu-SAR-bisPSMA PET/CT scan as determined at screening;
  • Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor;
  • Previous treatment with any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is discontinued prior to enrolment, 14 days must elapse after abiraterone discontinuation and 28 days after enzalutamide before participant can be enrolled) or low dose corticosteroids;
  • Previous treatment with any investigational agents within 4 weeks prior enrollment into the study;
  • Known hypersensitivity to the components of the investigational products or its analogues;
  • Transfusion for the sole purpose of making a participant eligible for study inclusion;
  • Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression;
  • Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation;
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
  • Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g. uncontrolled urinary incontinence, high dependency care);
  • Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clarity Pharmaceuticals +61 (0) 2 9209 4037 clinicaltrials@claritypharmaceuticals.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04868604
Other Study ID Numbers  ICMJE CLP05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Clarity Pharmaceuticals Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Clarity Pharmaceuticals Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clarity Pharmaceuticals Clarity Pharmaceuticals
PRS Account Clarity Pharmaceuticals Ltd
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP