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

NCT07567521 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: TR1189-2501-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Prostate Cancer

Keywords

Radiopharmaceutical Therapy; prostate cancer; Prostate Specific Membrane Antigen

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of AEs and SAEs

  Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) by monitoring adverse events, laboratory tests, vital signs, Electrocardiogram(ECG).

  From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

• Prostate Specific Antigen response (PSA50)

  The percentage of participants who achieved ≥ 50% decrease from baseline at 12 weeks after the first administration or later.

  About 12 months.

Secondary Outcomes (17)

• Peak concentration (Cmax)

  10 days following the first dose.

• AUC0-t

  10 days following the first dose.

• T1/2

  10 days following the first dose.

• Absorbed dose coefficients

  10 days following the first dose.

• Residence time

  10 days following the first dose.

Other Outcomes (2)

• Radiographic Progression Free Survival (rPFS)

  About 12 months.

• Overall Survival (OS)

  About 24 months.

Study Arms (3)

7.40MBq of TRC003

EXPERIMENTAL

Participants will receive 7.40 MBq (200 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment.

Drug: Radiopharmaceuticals

9.25 MBq of TRC003

EXPERIMENTAL

Participants will receive 9.25 MBq (250 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment.

Drug: Radiopharmaceuticals

11.10 MBq of TRC003

EXPERIMENTAL

Participants will receive 11.10 MBq (300 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment.

Drug: Radiopharmaceuticals

Interventions

Radiopharmaceuticals DRUG

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.

11.10 MBq of TRC003; 7.40MBq of TRC003; 9.25 MBq of TRC003

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have the ability to understand and sign ICF.
• Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate.
• Participants must have progressive mCRPC after treatment of ARPI or taxane-based chemotherapy.
• Participant must have been diagnosed with mCRPC with documented progressive disease.
• 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).
• Participants must have one or more PSMA-positive lesions whose PSMA uptake (SUVmax) is more than 2 fold of the blood pool.
• Participants with an ECOG performance status of 0 - 2.
• Participants must have adequate organ function
• For participants who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal Investigator during the study and for 6 months after last investigational product administration.

You may not qualify if:

• Participants with mixed histology of prostate cancer (e.g., neuroendocrine).
• Any FDG-positive and PSMA-negative target lesions.
• 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.
• 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.
• Known hypersensitivity to the components of the study therapy or its analogs.
• A superscan as seen in the baseline bone scan.
• Concurrent serious (as determined by the Investigator) medical conditions.
• Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.

Sponsors & Collaborators

• C Ray Therapeutics: lead

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital

Taiyuan, Shanxi, 030013, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiopharmaceuticals

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals

Study Officials

• Yan Wu, MD

  C Ray Therapeutics (Chengdu) Co., Ltd.

  STUDY DIRECTOR

• Dingwei Ye, MD, PhD

  Fudan University Shanghai Cancer Center, Fudan University

  STUDY CHAIR

• Nianzeng Xing, MD, PhD

  Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Jihong Liu, PhD

CONTACT

86-28-82706670; jihong.liu@c-raytherapeutics.com

Yan Wu, MD

CONTACT

86-28-82706670; yan.wu@c-raytherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: ICF will be shared from June 2026 to December 2029.
• Access Criteria: The International Committee of Medical Journal Editors (ICMJE) and its associated journal editorial staff.

Locations

CN (2)