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

Part of paid clinical trials in Stanford, California.

Sponsor
Clarity Pharmaceuticals Ltd
Study ID
NCT04868604
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 64Cu-SAR-bisPSMA — DRUG
    64Cu-SAR-bisPSMA
  • 67Cu-SAR-bisPSMA — DRUG
    67Cu-SAR-bisPSMA

Study Details

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.

Key Dates

Start date
Aug 11, 2021
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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 4 administrations of 67Cu-SAR-bisPSMA (dose will be determined based on cohort allocation). In the cohort expansion phase patients will receive up to 6 administrations of 67Cu-SAR-bisPSMA at the recommended dose level determined through dose escalation.

Primary Outcome Measure

Biodistribution of 64Cu-SAR-bisPSMA [ Time Frame: 48 hours ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstituteStanfordCalifornia94305
David Marcellus
Hong Song, MD (PRINCIPAL_INVESTIGATOR)
East Jefferson General HospitalRiver RidgeLouisiana70123-
BAMF HealthGrand RapidsMichigan49503
Brandon Mancini (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Geoffrey Johnson, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine at Barnes-Jewish HospitalSt LouisMissouri63110
Vikas Prasad, MD (PRINCIPAL_INVESTIGATOR)
XCancerOmahaNebraska68130
Tony Romero
[email protected]
402-690-3716
Luke Nordquist, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine at New York-PresbyterianNew YorkNew York10021
Scott Tagawa, MD (PRINCIPAL_INVESTIGATOR)

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