NCT05725070

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

January 23, 2023

Last Update Submit

October 5, 2023

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 28 days

Secondary Outcomes (3)

  • Safety and tolerability

    Up to 28 days

  • Body clearance

    Up to 2 days

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

    Up to 28 days

Study Arms (1)

Drug

EXPERIMENTAL

212Pb-NG001

Drug: 212Pb-NG001

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.

Drug

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Study Officials

  • Kjetil Berner, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 13, 2023

Study Start

March 6, 2023

Primary Completion

July 6, 2023

Study Completion

July 6, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

NO(1)