At a glance
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NCT06081686Phase 2RecruitingUpdate OverdueUpdated 25mo ago · Completion was 6mo agoPhase I/II Study to Evaluate the Safety and Tolerability, Radiation Dosimetry and Pharmacokinetics, and Efficacy of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Phase I:[177Lu]Lu-XT033 Injection and Phase II:[177Lu]Lu-XT033 Injection for Prostate Cancer. Currently recruiting, targeting 32 participants across 2 sites.
Signals
Detailed Summary
This was a multicenter, open-label, phase I/II study to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, and efficacy of \[177Lu\] Lu-XT033 injection in patients with metastatic prostate cancer, including a phase I study and a phase II extension study.
Study Details
Timeline
Interventions
Six subjects were enrolled in the 1.11 Gbq (30 mCi) group of \[177Lu\] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval .
Patients received \[177Lu\]Lu-XT033 Injection every 8 weeks (+/- 1 week) for a maximum of 6 cycles.