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

NCT ID: NCT05725070

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2023-07-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Metastatic Castration-resistant Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug

212Pb-NG001

Group Type EXPERIMENTAL

212Pb-NG001

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ARTBIO Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kjetil Berner, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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NG001-01

Identifier Type: -

Identifier Source: org_study_id

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