Back to resultsPhase 0/1 Study of 212Pb-NG001 in mCRPC
Primary Purpose
Metastatic Castration-resistant Prostate Cancer
Status
Completed
Phase
Early Phase 1
Locations
Norway
Study Type
Interventional
Intervention
212Pb-NG001
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer
Eligibility Criteria
Key Inclusion Criteria: ECOG performance status of 0 to 2 Life expectancy >6 months Histological, pathological, and/or cytological confirmation of prostate cancer Metastatic castration resistant prostate cancer Failure of conventional treatment or such treatment not available/accepted by patient PSMA avid mCRPC lesions confirmed by PSMA PET/CT Adequate hematopoietic, kidney and liver function Key Exclusion Criteria: Concurrent or other cancer diagnosis last two years, except for carcinoma in situ Concomitant diseases not compatible for radioactive therapy Previous PSMA-targeted radioligand therapy Concurrent serious (as determined by the Principal Investigator) medical conditions Note: Other protocol defined Inclusion/Exclusion criteria apply.
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug
Arm Description
212Pb-NG001
Outcomes
Primary Outcome Measures
Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001
To qualitatively determine whether 212Pb-NG001 can be used to produce images of sufficient clarity and sensitivity by SPECT/CT to confirm 212Pb-NG001 uptake and biodistribution.
Secondary Outcome Measures
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Body clearance
To study body clearance of 212Pb-NG001 by gamma camera imaging and by sample and probe measurements.
Therapeutic effect on prostate cancer as indicated by decreasing serum PSA and/or ALP
To explore any signals of therapeutic effects on the laboratory parameters: prostate specific antigen (PSA) and alkaline phosphatase (ALP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05725070
Brief Title
Phase 0/1 Study of 212Pb-NG001 in mCRPC
Official Title
Phase 0/1 Theragnostic Study in Patients With Metastatic Castration Resistant Prostate Cancer in Need of Salvage Therapy, Selected by 18F-PSMA-PET Imaging and Treated by Alpha-therapeutic Radioligand 212Pb-NG001
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
July 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARTBIO Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.
Detailed Description
This is a single site, open label, non-randomized, non-controlled intervention study with an initial microdosing run-in part (phase 0), followed by a conventional dose-escalation phase 1 part.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug
Arm Type
Experimental
Arm Description
212Pb-NG001
Intervention Type
Drug
Intervention Name(s)
212Pb-NG001
Intervention Description
212Pb-NG001 is a targeted alpha-emitting radiopharmaceutical conjugated to a PSMA targeting peptide.
Patients will receive an initial single 10 MBq dose IV to explore the imaging potential of 212Pb-NG001.
Primary Outcome Measure Information:
Title
Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001
Description
To qualitatively determine whether 212Pb-NG001 can be used to produce images of sufficient clarity and sensitivity by SPECT/CT to confirm 212Pb-NG001 uptake and biodistribution.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
Up to 28 days
Title
Body clearance
Description
To study body clearance of 212Pb-NG001 by gamma camera imaging and by sample and probe measurements.
Time Frame
Up to 2 days
Title
Therapeutic effect on prostate cancer as indicated by decreasing serum PSA and/or ALP
Description
To explore any signals of therapeutic effects on the laboratory parameters: prostate specific antigen (PSA) and alkaline phosphatase (ALP)
Time Frame
Up to 28 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
ECOG performance status of 0 to 2
Life expectancy >6 months
Histological, pathological, and/or cytological confirmation of prostate cancer
Metastatic castration resistant prostate cancer
Failure of conventional treatment or such treatment not available/accepted by patient
PSMA avid mCRPC lesions confirmed by PSMA PET/CT
Adequate hematopoietic, kidney and liver function
Key Exclusion Criteria:
Concurrent or other cancer diagnosis last two years, except for carcinoma in situ
Concomitant diseases not compatible for radioactive therapy
Previous PSMA-targeted radioligand therapy
Concurrent serious (as determined by the Principal Investigator) medical conditions
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjetil Berner, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Phase 0/1 Study of 212Pb-NG001 in mCRPC
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