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

ARTBIO

Status and phase: Completed; Early Phase 1

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: 212Pb-NG001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05725070

NG001-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Drug

Experimental group

Description:

212Pb-NG001

Treatment:

Drug: 212Pb-NG001