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RECRUITING
NCT06081686
PHASE1/PHASE2

Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer

Sponsor: Sinotau Pharmaceutical Group

View on ClinicalTrials.gov

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

DRUG

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 .

DRUG

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