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

NCT06081686 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-03

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Sinotau Pharmaceutical Group

    lead INDUSTRY

Principal Investigators

  • Dingwei Ye · Fudan University

  • Zhi Yang · Peking University Cancer Hospital & Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06081686 on ClinicalTrials.gov