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Completed

NCT Number: NCT05725070

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

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

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

212Pb-NG001

Drug

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.

Primary outcomes

  1. Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001

    Time frame: 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 outcomes

  1. Safety and tolerability

    Time frame: Up to 28 days

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

  2. Body clearance

    Time frame: Up to 2 days

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

  3. Therapeutic effect on prostate cancer as indicated by decreasing serum PSA and/or ALP

    Time frame: Up to 28 days

    To explore any signals of therapeutic effects on the laboratory parameters: prostate specific antigen (PSA) and alkaline phosphatase (ALP)

Sponsors and collaborators

Lead sponsor

ARTBIO Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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