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NOT YET RECRUITING
NCT07567521
PHASE1/PHASE2

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

Sponsor: C Ray Therapeutics

View on ClinicalTrials.gov

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

DRUG

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