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

2026년 5월 27일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

90

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
      • Shanghai, 중국, 200032
        • 아직 모집하지 않음
        • Fudan University Shanghai Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Dingwei Ye, MD, PhD
    • Shanxi
      • Taiyuan, Shanxi, 중국, 030013
        • 모병
        • Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital
        • 연락하다:
        • 수석 연구원:
          • Nianzeng Xing, MD, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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  • 고령자

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아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
실험적: 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.
의약품: 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.
실험적: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence and severity of AEs and SAEs
기간: 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)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Peak concentration (Cmax)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: About 12 months.
Time to radiographic soft tissue progression by RECIST v1.1 and PCWG3 criteria.
About 12 months.
Time to Progression (TTP)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
Radiographic Progression Free Survival (rPFS)
기간: 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)
기간: About 24 months.
Time to death due to any cause.
About 24 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

C Ray Therapeutics

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 22일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2029년 12월 30일

연구 등록 날짜

최초 제출

2026년 4월 24일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 27일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TR1189-2501-1

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 기간

ICF will be shared from June 2026 to December 2029.

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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