RecruitingPhase 1NCT07096128
A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer
A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer
Sponsor
Jinming Zhang
Enrollment
36 participants
Start Date
Aug 20, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria11
- 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 PSMA 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 undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.
- 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 Criteria7
- 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.
Interventions
DRUG[177Lu]Lu-PSMA-XT
\[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07096128