Clinical Trials /

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

NCT04868604

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECURE)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CLP05
  • NCT ID: NCT04868604

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Interventions

DrugSynonymsArms
64Cu-SAR-bisPSMA67Cu-SAR-bisPSMA
67Cu-SAR-bisPSMA67Cu-SAR-bisPSMA

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
67Cu-SAR-bisPSMAExperimentalIn 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.
  • 64Cu-SAR-bisPSMA
  • 67Cu-SAR-bisPSMA

Eligibility Criteria

        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 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 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 (> 1 cm in mean diameter) 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 any systemic radionuclide (e.g. 177Lu, Strontium-89,
             Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Radium-223, Iodine-131) within 6
             months of treatment initiation;

          -  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 EBRT is scheduled after enrollment into the
             study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Biodistribution of 64Cu-SAR-bisPSMA
Time Frame:48 hours
Safety Issue:
Description:Biodistribution will be calculated by utilizing the PET/CT scans.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Clarity Pharmaceuticals Ltd

Last Updated

June 11, 2021