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

Early Phase 1CompletedNCT05725070

ARTBIO Inc.3 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

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.

Time frame: Up to 28 days

Secondary Outcomes

Safety and tolerability

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame: Up to 28 days

Body clearance

To study body clearance of 212Pb-NG001 by gamma camera imaging and by sample and probe measurements.

Time frame: 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)

Time frame: Up to 28 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.