TheranosticTrials.org

Clinical Trial · NCT07660211

Clinical Evaluation of 177Lu-PSMA-VG01 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer （mCRPC）

Overview

This is a phase I clinical trial conducted in participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). After confirmation of PSMA positivity, participants receive intravenous administration of 177Lu-PSMA-VG01. The objectives are: to evaluate the biodistribution, radiation dosimetry, safety and tolerability of 177Lu-PSMA-VG01 in participants; and to assess the pharmacokinetics (PK), preliminary anti-tumor activity, and in vivo stability of 177Lu-PSMA-VG01 in participants.

Sponsor

Fortis Therapeutics, Inc.

Phase

Phase 1

Contacts

Xiaobo Su (CONTACT)

xiaobo.su@vitsgen.com

086+0632-2989679

ClinicalTrials.gov

NCT07660211

Drug / Compound

PSMA-VG01

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

Eligibility

Inclusion

  • ECOG Performance Status score: 0 to 2.
  • Histologically or cytologically confirmed prostate cancer with no standard treatment options available, or failure/intolerance to standard therapies, or inability to access standard treatment.

Exclusion

  • Having symptomatic spinal cord compression or clinical/imaging findings suggestive of impending spinal cord compression.
  • Having a history of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; a history of severe autoimmune diseases deemed unsuitable for enrollment by the investigator; or requiring immunosuppressive therapy for allogeneic organ transplantation.
  • Having received systemic or local radionuclide therapy within 3 months prior to the first dose.
  • Having undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or requiring elective surgery during the trial period.
  • Having uncontrolled third-space fluid accumulations (such as significant pleural effusion, ascites or pericardial effusion) deemed unsuitable for enrollment by the investigator.
  • Having received anti-tumor therapies such as chemotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose of the investigational product, or planning to receive such therapies during the study period.