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

Sponsor
ARTBIO Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05725070
Collaborator
(none)
23
Enrollment
1
Location
1
Arm
7
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Safety and tolerability [Up to 28 days]

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

  2. Body clearance [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 [Up to 28 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway

Sponsors and Collaborators

  • ARTBIO Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ARTBIO Inc.
ClinicalTrials.gov Identifier:
NCT05725070
Other Study ID Numbers:
  • NG001-01
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Feb 15, 2023