64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

NCT05249127 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CLP06
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.

Conditions

Biochemical Recurrence of Malignant Neoplasm of Prostate

Outcome Measures

Primary Outcomes (5)

• Safety and Tolerability

  Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0

  up to 7 days post injection

• Participant-level Correct Detection Rate (CDR)- Day 0

  The percentage of TP participants on the Day 0 scan out of all participants with a Day 0 scan.

  Day 0 (1- 4 hours) post injection

• Participant-level CDR- Day 1

  The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.

  Day 1 (24+/-6 Hours) post injection

• Region-level Positive Predictive Value (PPV)- Day 0

  The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.

  Day 0 (1- 4 hours)

• Region-level PPV- Day 1

  The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.

  Day 1 (24 +/- 6 hours)

Secondary Outcomes (10)

• Biodistribution of 64Cu-SAR-bisPSMA- SUVmean

  Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection

• Biodistribution of 64Cu-SAR-bisPSMA- SUVmax

  Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)

• Biodistribution of 64Cu-SAR-bisPSMA- SUVr

  Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)

• Participant-level PPV

  Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)

• Participant-level Detection Rate (DR)

  Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)

Study Arms (1)

64Cu-SAR-bisPSMA

EXPERIMENTAL

Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-bisPSMA.

Drug: 64Cu-SAR-bisPSMA

Interventions

64Cu-SAR-bisPSMA DRUG

64Cu-SAR-bisPSMA

64Cu-SAR-bisPSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Signed informed consent.
• Life expectancy ≥ 12 weeks as determined by the Investigator.
• Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
• Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of:
• Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or
• Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).
• Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0.
• The Eastern Cooperative Oncology performance status 0-2.
• Adequate recovery from acute toxic effects of any prior therapy.
• Estimated Glomerular Filtration Rate of 30 mL/min or higher.
• Adequate liver function.
• For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

You may not qualify if:

• Participants who received other investigational agents within 28 days prior to Day 0.
• Participants administered any high energy (\>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0.
• Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC.
• Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
• Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Sponsors & Collaborators

• Clarity Pharmaceuticals Ltd: lead

Study Sites (5)

Tower Urology

Los Angeles, California, 90048, United States

Location

GU Research Network

Omaha, Nebraska, 68130, United States

Location

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology San Antonio

San Antonio, Texas, 78258, United States

Location

Results Point of Contact

• Title: Dr Othon Gervasio, Chief Medical Officer
• Organization: Clarity Pharmaceuticals

info@claritypharmaceuticals.com

+61 2 9209 4037

Study Officials

• Othon Gervasio

  Clarity Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 21, 2022
• Study Start: April 11, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)