Treatment with [177Lu] Lu-XT033 Injection for metastatic prostate cancer

Phase I/II Study to Evaluate the Safety and Tolerability, Radiation Dosimetry and Pharmacokinetics, and Efficacy of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer

This study is testing a new injection for metastatic prostate cancer to see if it is safe and effective for patients.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: Sinotau Pharmaceutical Group (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06081686 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label study evaluates the safety, tolerability, and efficacy of [177Lu] Lu-XT033 injection in patients with metastatic prostate cancer. It consists of a phase I component, where different doses are administered to assess safety, followed by a phase II extension for those who meet specific response criteria. Participants undergo a screening period, treatment with up to six cycles of the injection, and a follow-up period to monitor outcomes. The study aims to gather data on radiation dosimetry and pharmacokinetics as well.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed metastatic castration-resistant prostate cancer who have previously received certain treatments.

Not a fit: Patients who have not been previously treated with at least one novel androgen axis drug or have not progressed after two taxane regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic prostate cancer.

How similar studies have performed: Other studies using targeted radioligand therapies for prostate cancer have shown promising results, indicating potential success for this approach.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Dingwei Ye — Fudan University
• Study coordinator: Shan Zhang

Conditions: Prostate Cancer, [177Lu]Lu-XT033 Injection