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

Early Phase 1

Completed

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: 212Pb-NG001

• Registration Number: NCT05725070
• Lead Sponsor: ARTBIO Inc.

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.

Study Timeline

• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Study Start: 2023-03-06
• Primary Completion: 2023-07-06
• Study Completion: 2023-07-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug	212Pb-NG001	212Pb-NG001

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway