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

27 maggio 2026 aggiornato da: C Ray Therapeutics

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)

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a prospective, randomized, open-label, phase 1/2 study on adult patients with PSMA-positive metastatic castration-resistant prostate cancer. Approximately 90 eligible participants will be enrolled and randomized 1:1:1 to three dose cohorts. The first six participants in each cohort will be assessed for dose-limiting toxicity (DLT) during the first treatment cycle.

Each eligible participant will receive one of the predefined doses of TRC003 (7.40, 9.25, 11.10 MBq) by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. All participants in this study may undergo dose modification based on the assessment of safety or efficacy by the investigators.

Any adverse events (AEs) observed or reported will be recorded. Blood and urine samples will be collected after the first administration of TRC003 on 6 participants in each cohort for pharmacokinetics (blood concentration of TRC003). 2 eligible participants of each cohort (total 6 participants) will undergo SPECT/CT for dosimetry after informed consent. All participants will be assessed PSA every 4 weeks. CT with contrast /MRI and bone scan will be evaluated every 8 weeks until proved disease progression by RECIST version 1.1 and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
      • Shanghai, Cina, 200032
        • Non ancora reclutamento
        • Fudan University Shanghai Cancer Center
        • Contatto:
        • Investigatore principale:
          • Dingwei Ye, MD, PhD
    • Shanxi
      • Taiyuan, Shanxi, Cina, 030013
        • Reclutamento
        • Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital
        • Contatto:
        • Investigatore principale:
          • Nianzeng Xing, MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Transfusion for the sole purpose of making a participant eligible for study inclusion within 28 days before administration.
  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 7.40MBq of TRC003
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.
Droga: 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.
Sperimentale: 9.25 MBq of TRC003
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.
Droga: 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.
Sperimentale: 11.10 MBq of TRC003
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.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence and severity of AEs and SAEs
Lasso di tempo: 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.
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)
Lasso di tempo: About 12 months.
The percentage of participants who achieved ≥ 50% decrease from baseline at 12 weeks after the first administration or later.
About 12 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peak concentration (Cmax)
Lasso di tempo: 10 days following the first dose.
The maximum measured concentration of TRC003 in the body after administration.
10 days following the first dose.
AUC0-t
Lasso di tempo: 10 days following the first dose.
Area under the concentration-time curve from time 0 to the last measurable concentration
10 days following the first dose.
T1/2
Lasso di tempo: 10 days following the first dose.
Time required for the drug concentration to decrease by 50%.
10 days following the first dose.
Absorbed dose coefficients
Lasso di tempo: 10 days following the first dose.
The ratio of absorbed dose in a target tissue to the total activity injected, representing dose delivered per unit activity.
10 days following the first dose.
Residence time
Lasso di tempo: 10 days following the first dose.
The total time that TRC003 remains in a target organ or the body.
10 days following the first dose.
Effective dose
Lasso di tempo: 10 days following the first dose.
Effective dose is the total radiation dose adjusted for organ sensitivity, used to estimate the risk of radiation-induced health effects.
10 days following the first dose.
Prostate Specific Antigen response (PSA90)
Lasso di tempo: About 12 months.
The percentage of participants who achieved ≥ 90% decrease from baseline at 12 weeks after the first administration or later
About 12 months.
Biochemical Progression Free Survival (bPFS)
Lasso di tempo: About 12 months.
Time to PSA progression by PCWG3 criteria (after decline from baseline: record time from start of therapy to first PSA increase that is ≥ 25% and ≥ 2 ng/mL above the nadir, and which is confirmed by a second value ≥ 3 weeks later).
About 12 months.
Overall Response Rate (ORR)
Lasso di tempo: About 12 months
The proportion of participants with Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) from baseline until radiographic progression or death, whichever comes first.
About 12 months
Disease Control Rate (DCR)
Lasso di tempo: About 12 months.
The proportion of participants with BOR of confirmed CR, PR, Stable Disease (SD) or non-CR/non-progressive disease (PD) from baseline until radiographic progression or death, whichever comes first.
About 12 months.
Duration of Response (DoR)
Lasso di tempo: About 12 months.
Time between the date of first documented response and the date of first documented radiographic progression or death due to any cause by RECIST v1.1 and PCWG3 criteria.
About 12 months.
Time to first radiographic Soft Tissue Progression (TTSTP)
Lasso di tempo: About 12 months.
Time to radiographic soft tissue progression by RECIST v1.1 and PCWG3 criteria.
About 12 months.
Time to Progression (TTP)
Lasso di tempo: About 12 months.
Time to the first documented radiographic progression by RECIST v1.1 and PCWG3 criteria.
About 12 months.
Time to first Symptomatic Skeletal Event (TTSSE)
Lasso di tempo: About 12 months.
Time to the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first.
About 12 months.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Lasso di tempo: About 12 months.
A qusetionnaire to assess health-related quality of life (HRQOL) in cancer patients by patient-reported outcome (PRO) measure. The standard range of EORTC QLQ-C30 is 0-100 points. For Functional Scales, higher score means better function, better health status, higher quality of life. For Symptom Scales & Single Symptom Items, higher score means more severe symptoms / greater burden.
About 12 months.
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Lasso di tempo: About 12 months.
A disease-specific, patient-reported outcome (PRO) questionnaire designed to measure health-related quality of life (HRQoL) in men with prostate cancer. FACT-P Total Score range is 0-160. Higher score means better quality of life, fewer symptoms, better functional status.
About 12 months.
Brief Pain Inventory - Short Form (BPI-SF)
Lasso di tempo: About 12 months.
A widely used, validated patient-reported outcome (PRO) tool designed to assess the severity of pain and the impact of pain on daily functioning. BPI-SF Total Score range is 0-110. Higher total score means worse overall pain and greater pain interference with daily life.
About 12 months.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Radiographic Progression Free Survival (rPFS)
Lasso di tempo: About 12 months.
Time to radiographic progression with contrast CT/MRI, or death due to any cause by RECIST v1.1 and PCWG3 criteria.
About 12 months.
Overall Survival (OS)
Lasso di tempo: About 24 months.
Time to death due to any cause.
About 24 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

C Ray Therapeutics

Investigatori

  • Direttore dello studio: Yan Wu, MD, C Ray Therapeutics (Chengdu) Co., Ltd.
  • Cattedra di studio: Dingwei Ye, MD, PhD, Fudan University Shanghai Cancer Center, Fudan University
  • Cattedra di studio: Nianzeng Xing, MD, PhD, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 maggio 2026

Completamento primario (Stimato)

30 dicembre 2027

Completamento dello studio (Stimato)

30 dicembre 2029

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TR1189-2501-1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Periodo di condivisione IPD

ICF will be shared from June 2026 to December 2029.

Criteri di accesso alla condivisione IPD

The International Committee of Medical Journal Editors (ICMJE) and its associated journal editorial staff.

Tipo di informazioni di supporto alla condivisione IPD

  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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