TheranosticTrials.org

Clinical Trial · NCT06081686

Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer

Overview

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.

Sponsor

Sinotau Pharmaceutical Group

Phase

Phase 1/2

Contacts

Shan Zhang (CONTACT)

zhangshan@sinotau.com

010-52805710

Zhi Yang (PRINCIPAL_INVESTIGATOR)

Dingwei Ye (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06081686

Drug / Compound

XT033

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • 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.
  • Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
  • 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 a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
  • Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
  • Patients must have a life expectancy \>6 months.
  • Patients must have progressive mCRPC.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have adequate organ function。

Exclusion

  • Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
  • Patients with a history of Central Nervous System (CNS) metastases.
  • Known other malignancies.
  • 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.
  • A superscan as seen in the baseline bone scan.
  • Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.
  • Known hypersensitivity to the components of the study therapy or its analogs.