Status:
RECRUITING
Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
Lead Sponsor:
Sinotau Pharmaceutical Group
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 p...
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 I...
Eligibility Criteria
Inclusion
- Patients must have the ability to understand and sign an approved informed consent form (ICF).
- Patients must be \>= 18 and \<＝80 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must have a life expectancy \>6 months.
- Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
- Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
- Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
- Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)； Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens.
- Patients must have progressive mCRPC.
- Patients must have adequate organ function。
- Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.
Exclusion
- Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
- Known other malignancies.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
- Known hypersensitivity to the components of the study therapy or its analogs.
- A superscan as seen in the baseline bone scan.
- Patients with a history of Central Nervous System (CNS) metastases.
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06081686
Start Date
September 13 2023
End Date
December 1 2025
Last Update
May 3 2024
Active Locations (2)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100042
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032