Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

27. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

90

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
      • Shanghai, China, 200032
        • Noch keine Rekrutierung
        • Fudan University Shanghai Cancer Center
        • Kontakt:
        • Hauptermittler:
          • Dingwei Ye, MD, PhD
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Rekrutierung
        • Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital
        • Kontakt:
        • Hauptermittler:
          • Nianzeng Xing, MD, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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.
Experimental: 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.
Arzneimittel: 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.
Experimental: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence and severity of AEs and SAEs
Zeitfenster: 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)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peak concentration (Cmax)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: About 12 months.
Time to radiographic soft tissue progression by RECIST v1.1 and PCWG3 criteria.
About 12 months.
Time to Progression (TTP)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Radiographic Progression Free Survival (rPFS)
Zeitfenster: 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)
Zeitfenster: About 24 months.
Time to death due to any cause.
About 24 months.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

C Ray Therapeutics

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Mai 2026

Primärer Abschluss (Geschätzt)

30. Dezember 2027

Studienabschluss (Geschätzt)

30. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

24. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. April 2026

Zuerst gepostet (Tatsächlich)

5. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TR1189-2501-1

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

IPD-Sharing-Zeitrahmen

ICF will be shared from June 2026 to December 2029.

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren