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Lutetium Lu 177 JH020002 in Advanced Prostate Cancer
NCT06139575Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2023
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Bivision Pharmaceuticals
- Modality
- Radiopharmaceutical
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label, single-arm trial of lutetium Lu-177 JH020002 in prostate cancer (PCa), sponsored by Bivision Pharmaceuticals. Primary endpoints: Dose Limiting Toxicity at 2 years, Maximum Tolerated Dose at 2 years and 2 more. Started Dec 2023; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Lutetium Lu 177 JH020002 Injection
Patients receive Lutetium Lu 177 JH020002 Injection every 6 weeks for a maximum of 6 doses.
03
Who it enrols
Adult males with advanced prostate adenocarcinoma, ECOG 0-2, life expectancy >6 months, castrate testosterone levels, without prior PSMA-targeted radioligand therapy or recent systemic/radiotherapy.
04
Endpoints
Primary
Dose Limiting Toxicity
Maximum Tolerated Dose
Recommended Phase 2 Dose
Prostate-Specific Antigen response rate
Secondary
Radiation Dosimetry
Maximum plasma concentration
Time to maximum plasma concentration
Terminal elimination half-life
Total systemic clearance
Area under the plasma concentration-time curve from time zero to the last measurable concentration
Area under the plasma concentration-time curve from time zero extrapolated to infinite time
Volume of distribution during the terminal phase following intravenous elimination
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