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

NCT07567521 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-05

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • C Ray Therapeutics

    lead INDUSTRY

Principal Investigators

  • Yan Wu, MD · C Ray Therapeutics (Chengdu) Co., Ltd.

  • Dingwei Ye, MD, PhD · Fudan University Shanghai Cancer Center, Fudan University

  • Nianzeng Xing, MD, PhD · Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-12-30
Completion
2029-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07567521 on ClinicalTrials.gov