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

Prostate Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT06081686
• Study type: Interventional
• Source: Sinotau Pharmaceutical Group
• Contact: Shan Zhang
• Phone: 010-52805710
• Email: zhangshan@sinotau.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 13, 2023
• Completion date: December 2025