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Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
Sponsor: Sinotau Pharmaceutical Group
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.
Official title: Phase 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
Key Details
Gender
MALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2023-09-13
Completion Date
2025-12
Last Updated
2024-05-03
Healthy Volunteers
No
Conditions
Interventions
Phase I:[177Lu]Lu-XT033 Injection
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 .
Phase II:[177Lu]Lu-XT033 Injection
Patients received \[177Lu\]Lu-XT033 Injection every 8 weeks (+/- 1 week) for a maximum of 6 cycles.
Locations (2)
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China