NCT06081686

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study for each participant consisted of a Screening period, a Treatment period and a Follow-up period. In phase I,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 for a total of 4 doses.In phase II,Subjects who met the inclusion and exclusion criteria were treated with \[177Lu\] Lu-XT033 injection at the recommended phase II dose（RP2D）.After Cycle 4 treatment and prior to Cycle 5 treatment, the investigator assessed the following criteria to determine whether: The patient showed evidence of response (i.e. radiological, PSA, clinical benefit) The patient had signs of residual disease on CT with contrast/MRI or bone scan The patient had shown good tolerance to the \[177Lu\] Lu-XT033 Injection If the patient met all of the criteria above and agreed to continue with additional treatment of \[177Lu\] Lu-XT033, the Investigator could administer 2 additional cycles. A maximum of 6 cycles of \[177Lu\] Lu-XT033 as allowed. All subjects continued to undergo safety, tolerability, and efficacy assessments until the study-specified visit occurred or the subject was lost to follow-up or death whichever came first.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-13
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-10-13
• Last updated: 2024-05-03

Locations

2 sites across 1 country: China