Actively Recruiting
Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
Led by Sinotau Pharmaceutical Group · Updated on 2024-05-03
32
Participants Needed
2
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Age 18 to 80 years
- ECOG performance status 0 or 1
- Life expectancy greater than 6 months
- Confirmed diagnosis of prostate cancer by biopsy or pathology
- Positive 68Ga-PSMA-11 PET/CT scan
- Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
- Received at least one novel androgen axis drug (e.g., enzalutamide or abiraterone)
- Previously treated with 1 to 2 taxane chemotherapy regimens
- Evidence of progressive metastatic castration-resistant prostate cancer (mCRPC)
- Adequate organ function
- Use of effective contraception if of childbearing potential during treatment and for 6 months after last dose
You will not qualify if you...
- Previous treatment within 6 months with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation, or prior PSMA-targeted radioligand therapy
- Presence of other known malignancies
- Systemic anti-cancer therapy within 28 days prior to enrollment
- Known allergy to study drug components or analogs
- Superscan on baseline bone scan
- History of central nervous system metastases
- Uncontrolled illness such as active infection, symptomatic congestive heart failure, cardiac arrhythmia, or severe complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100042
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
Research Team
S
Shan Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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