Clinical Trials in China / NCT07096128
Recruiting
Phase 1
A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer
NCT07096128 · tracked via the Priya Life Science China tracker
Condition(s) studied
mCRPC
Investigational drug(s) / intervention(s)
[177Lu]Lu-PSMA-XT
[177Lu]Lu-PSMA-XT: \[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.
Study 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
Inclusion Criteria:
1. Patients must have the ability to understand and sign an approved informed consent form (ICF).
2. Patients must be \>= 18 and \<＝80 years of age.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Patients must have a life expectancy \>6 months.
5. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
6. Patients must be PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
7. Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
8. 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.
9. Patients must have progressive mCRPC.
10. Patients must have adequate organ function。
11. 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 Criteria:
1. 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.
2. Known other malignancies.
3. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
4. Known hypersensitivity to the components of the study therapy or its analogs.
5. A superscan as seen in the baseline bone scan.
6. Patients with a history of Central Nervous System (CNS) metastases.
7. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.
Primary outcome measure(s)
- 1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — Through study completion, assessed up to 2 years
To evaluate the safety and tolerability of \[177Lu\]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc. - Dose-limiting toxicity（DLT） — Through study completion, assessed up to 2 years
Incidence and severity of dose-limiting toxicities. - Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection — From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months
Quantitate the absorbed radiation doses (expressed as Gy/MBq) of administered \[177Lu\]Lu-PSMA-XT to kidneys, liver, lungs, spleen, bone/red marrow and salivary glands.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| Mianyang Central Hospital | Beijing | Beijing Municipality | Recruiting |
| The First Medical Center, Chinese PLA General Hospital | Beijing | Beijing Municipality | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07096128 on ClinicalTrials.gov ↗ ← All trials in China