NCT06081686 Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer
| NCT ID | NCT06081686 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sinotau Pharmaceutical Group |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2023-09-13 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 patients with metastatic prostate cancer, including a phase I study and a phase II extension study.
Eligibility Criteria
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 68Ga-PSMA-11 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 with at least 1, but no more than 2 previous taxane regimens. 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.
Contact & Investigator
Dingwei Ye
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06081686 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06081686 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06081686 currently recruiting?
Yes, NCT06081686 is actively recruiting participants. Contact the research team at zhangshan@sinotau.com for enrollment information.
Where is the NCT06081686 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China.
Who is sponsoring the NCT06081686 clinical trial?
NCT06081686 is sponsored by Sinotau Pharmaceutical Group. The principal investigator is Dingwei Ye at Fudan University. The trial plans to enroll 32 participants.
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