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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 13, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Prostate Cancer
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.

Trial Locations (2)

100042

RECRUITING

Peking University Cancer Hospital, Beijing

200032

NOT_YET_RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Sinotau Pharmaceutical Group

INDUSTRY