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A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC
Sponsor: C Ray Therapeutics
Summary
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.
Official title: A Prospective, Open-label, Randomized, Phase 1/2 Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-06-15
Completion Date
2029-12-30
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
Radiopharmaceuticals
TRC003 is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. TRC003 is a 225Ac-labeled novel molecule for targeted alpha therapy (TAT), which delivers alpha-particle radiation specifically to prostate cancer cells expressing PSMA. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them.
Locations (2)
Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital
Taiyuan, Shanxi, China
Fudan University Shanghai Cancer Center
Shanghai, China