Metastatic Castration-resistant Prostate Cancer
Conditions
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.
Interventions
DRUG212Pb-NG001
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.
Sponsors
ARTBIO Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Up to 28 days | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Body clearance | Up to 2 days | 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 | Up to 28 days | To explore any signals of therapeutic effects on the laboratory parameters: prostate specific antigen (PSA) and alkaline phosphatase (ALP) |
Countries
Norway
Outcome results
None listed