Metastatic Castration-resistant Prostate CancerEarly Phase 1NCT05725070
Phase 0/1 Study of 212Pb-NG001 in mCRPC
A Early Phase 1 study testing 212Pb-NG001 in people with Metastatic Castration-resistant Prostate Cancer, run by ARTBIO Inc. at 1 site in Norway.
Trial summary
The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- 212Pb-NG001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- 6 Mar 2023to 6 Jul 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.
Read the 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.
- Being tested
- 212Pb-NG001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
212Pb-NG001Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | 212Pb-NG001 Receives: Drug: 212Pb-NG001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days
Secondary outcomes (3)
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to 28 days
Body clearance
To study body clearance of 212Pb-NG001 by gamma camera imaging and by sample and probe measurements.
Measured: Up to 2 days
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)
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start6 Mar 2023
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARTBIO Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kjetil Berner, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725070
- Sponsor's protocol ID
- NG001-01
- Status last verified
- Oct 2023
- First submitted
- 23 Jan 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05725070
- Acronym / sponsor ID
- NG001-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ARTBIO Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: 212Pb-NG001212Pb-NG001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 212Pb-NG001212Pb-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. | Drug | Drug |
Primary outcome
Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001
Time frame: Up to 28 days
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.
3 secondary outcomes
Safety and tolerability
Time frame: Up to 28 days
Body clearance
Time frame: Up to 2 days
Therapeutic effect on prostate cancer as indicated by decreasing serum PSA and/or ALP
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
Related trials for Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjetil Berner, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 212Pb-NG001 in people with Metastatic Castration-resistant Prostate Cancer, run by ARTBIO Inc. at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001 (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.