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Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection

NCT05413850 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-05-14

No results posted yet for this study

Summary

To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Conditions

Interventions

DIAGNOSTIC_TEST

18F-rhPSMA-7.3 injection (in phase 1 only)

18F-rhPSMA-7.3 (in phase 1 only) at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease.

DRUG

Lutetium (177Lu) rhPSMA-10.1 Injection

Therapeutic cycles of 177Lu-rhPSMA-10.1

Sponsors & Collaborators

  • PSI CRO

    collaborator INDUSTRY

  • Blue Earth Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Blue Earth Therapeutics · Blue Earth Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2026-08-27
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05413850 on ClinicalTrials.gov