TheranosticTrials.org

Clinical Trial · NCT07567521

A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC

Overview

The purpose of this study is to evaluate safety and tolerability, pharmacokinetics （PK）, efficacy of TRC003 injection in patients with progressive PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibitor (ARPI) or taxane-based chemotherapy. We plan to recruit 90 participants who will be randomly assigned to 1 of 3 dose cohorts (30 cases per dose cohort) with up to 6 cycles of treatment in this study.

Sponsor

TerSera Therapeutics

Phase

Phase 1/2

Contacts

Yan Wu, MD (CONTACT)

yan.wu@c-raytherapeutics.com

86-28-82706670

Yan Wu, MD (STUDY_DIRECTOR)

Dingwei Ye, MD, PhD (STUDY_CHAIR)

Jihong Liu, PhD (CONTACT)

jihong.liu@c-raytherapeutics.com

86-28-82706670

Nianzeng Xing, MD, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT07567521

Drug / Compound

TRC003

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

Eligibility

Inclusion

  • Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate.
  • Participants must have prior orchiectomy and/or ongoing androgen-deprivation therapy with a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
  • Participant must have been diagnosed with mCRPC with documented progressive disease.
  • * Participants must have the ability to understand and sign ICF.
  • Participants must have progressive mCRPC after treatment of ARPI or taxane-based chemotherapy.

Exclusion

  • Any investigational agents and other concurrent chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy (androgen-deprivation therapy excepted) within 28 days or 5 half-lives prior to day of administration, whichever is longer.
  • * Participants with mixed histology of prostate cancer (e.g., neuroendocrine).
  • Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks before enrollment.
  • Previous bone-targeted therapy cannot be taken with a stable dose within 4 weeks before enrollment.
  • Any FDG-positive and PSMA-negative target lesions.