Phase 0/1 Study of 212Pb-NG001 in mCRPC

Metastatic Castration-resistant Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725070
• Other study ID #: NG001-01
• Status: Completed
• Phase: Early Phase 1
• Start date: March 6, 2023
• Est. completion date: July 6, 2023

Study information

• Verified date: October 2023
• Source: ARTBIO Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 6, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 212Pb-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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
ARTBIO Inc.

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 28 days
Secondary	Safety and tolerability	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Up to 28 days
Secondary	Body clearance	To study body clearance of 212Pb-NG001 by gamma camera imaging and by sample and probe measurements.	Up to 2 days
Secondary	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)	Up to 28 days