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

October 5, 2023 updated by: ARTBIO Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug
212Pb-NG001
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: Up to 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Up to 28 days
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.
Up to 2 days
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)
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARTBIO Inc.

Investigators

  • Principal Investigator: Kjetil Berner, MD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Actual)

July 6, 2023

Study Completion (Actual)

July 6, 2023

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 2, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NG001-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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