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Recruiting Phase 1

A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer

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About this study

The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC

Condition
Metastatic Castration-Resistant Prostate Cancer Patients
Tested
225Ac-PSMA-XT
Sponsor
Xiaorong Sun

Who can join

Age
18 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 18 years
  • Eligible sex: Male
  • Study condition: Metastatic Castration-Resistant Prostate Cancer Patients
  • have the ability to understand and sign an approved informed consent form (ICF).
  • \>= 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • have a life expectancy \>6 months.
  • have histological, pathological, and/or cytological confirmation of prostate cancer.
  • PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive
  • have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
  • 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.
  • progressive mCRPC.
  • 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 7

  • 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.

Where

1 site, 1 recruiting

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Recruiting

Potential match only. Final eligibility is determined by the study team.