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진행성/전이성 고형 종양 참가자의 Raludotatug Deruxtecan에 대한 연구(REJOICE-PanTumor01)

2026년 9월 21일 업데이트: Daiichi Sankyo

REJOICE-PanTumor01: 진행성/전이성 고형 종양이 있는 참가자를 대상으로 Raludotatug Deruxtecan(R-DXd)의 효능 및 안전성을 평가하기 위한 2상, 다기관, 공개 라벨, 범종양 시험

This pan-tumor trial is designed as a signal-seeking trial to assess efficacy and safety of raludotatug deruxtecan (R-DXd) monotherapy in locally advanced or metastatic solid tumors with various cadherin-6 (CDH6) expression levels, including gynecological cancers (endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer) and genitourinary cancers (urothelial cancer and clear cell renal cell carcinoma [ccRCC]).

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

This trial is designed to evaluate the efficacy and safety of R-DXd in locally advanced or metastatic solid tumors with various CDH6 expression levels. Solid tumor types will include gynecological cancers (endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer) and genitourinary cancers (urothelial cancer and ccRCC).

For all cohorts except ccRCC, the primary endpoint will be objective response rate (ORR) by investigator assessment per RECIST 1.1. For the ccRCC cohort, the primary endpoint will be disease control rate (DCR) by investigator assessment per RECIST 1.1. All cohorts will also have the assessment of safety and tolerability as another primary objective.

연구 유형

중재적

등록 (추정된)

335

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 대한민국
      • Goyang-si, 대한민국, 10408
        • National Cancer Center
      • Seoul, 대한민국, 05505
        • Asan Medical Center
      • Seoul, 대한민국, 06351
        • Samsung Medical Center
      • Seoul, 대한민국, 03722
        • Severance Hospital
  • 덴마크
      • Copenhagen, 덴마크, 2100
        • Herlev og Gentofte Hosp
  • 미국
    • Georgia
      • Marietta, Georgia, 미국, 30060
        • Northside Hospital
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan Comprehensive Cancer Center Michigan Medicine
    • New Jersey
      • East Brunswick, New Jersey, 미국, 08816
        • Astera Cancer Care
    • New York
      • Albany, New York, 미국, 12208
        • Women's Cancer Care Associates
      • New York, New York, 미국, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Westbury, New York, 미국, 11590
        • Clinical Research Alliance
    • Tennessee
      • Germantown, Tennessee, 미국, 38138
        • West Cancer Center and Research Institute
    • Texas
      • Houston, Texas, 미국, 77030
        • The University of Texas MD Anderson Cancer Center
  • 벨기에
      • Leuven, 벨기에, 3000
        • UZ Leuven Gynaec onco
      • Wilrijk, 벨기에, 2610
        • ZAS Sint-Augustinus
  • 스페인
      • A Coruña, 스페인, 15006
        • Hospital Universitario de A Coruña
      • Barcelona, 스페인, 08035
        • Vall d'Hebron University Hospital
      • Barcelona, 스페인, 08041
        • Hospital de Sant Pau
      • Madrid, 스페인, 28041
        • Hospital 12 Octubre
      • Madrid, 스페인, 28027
        • The Clínica Universidad de Navarra Madrid
      • Madrid, 스페인, 28033
        • Md Anderson Cancer Centre
      • Málaga, 스페인, 29010
        • Hospital Universitario Virgen de la Victoria
  • 이탈리아
      • Catania, 이탈리아, 95126
        • AO per lEmergenza Cannizzaro
      • Genova, 이탈리아, 16132
        • Irccs Ospedale San Martino
      • Meldola, 이탈리아, 47014
        • IRCCS Dino Amadori - IRST
      • Milan, 이탈리아, 20132
        • IRCCS San Raffaele
      • Milan, 이탈리아, 40121
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Naples, 이탈리아, 80131
        • Federico II Hospital
      • Terni, 이탈리아, 05100
        • Azienda Ospedaliera S Maria
  • 일본
      • Akashi, 일본, 13-70
        • Hyogo Cancer Center
      • Chūōku, 일본, 104-0045
        • National Cancer Center Hospital
      • Fukuoka, 일본, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Hidaka, 일본, 1397-1
        • Saitama Medical University International Medical Center
      • Kashiwa, 일본, 277-8577
        • National Cancer Center Hospital East
      • Kōtoku, 일본
        • The Cancer Institute Hospital of Jfcr
      • Nagoya, 일본, 464-8681
        • Aichi Cancer Centre
      • Osaka, 일본, 541-8567
        • Osaka International Cancer Institute
  • 중국
      • Changsha, 중국, 410013
        • Hunan Cancer Hospital
      • Shanghai, 중국, 200000
        • Shanghai Cancer center
  • 프랑스
      • Caen, 프랑스, 14000
        • François Baclesse Center
      • Dijon, 프랑스, 21079
        • Centre Georges-François Leclerc
      • Lille, 프랑스, 59 000
        • Centre Oscar Lambret
      • Lyon, 프랑스, 69008
        • Centre Leon Berard
      • Paris, 프랑스, 75012
        • Grp Hsp Diac Croix Saint Simon
      • Plérin, 프랑스, 22190
        • Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie
      • Saint-Herblain, 프랑스, 44805
        • Ico - Site René Gauducheau
      • Toulouse, 프랑스, 31100
        • Institut Claudius Regaud
      • Villejuif, 프랑스, 94800
        • Gustave Roussy

참여기준

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

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Participants must meet all of the following criteria to be eligible for enrollment into the trial:

  1. Adults greater than or equal to ( ≥) 18 years of age on the day of signing the informed consent form (ICF).

  2. Participants must have at least 1 lesion, amenable to biopsy, and must consent to provide a pre-treatment biopsy from a primary and/or metastatic lesion.

  3. Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment.

  4. Participants must have progressed radiologically on or after their most recent line of systemic therapy.

  5. Eastern Cooperative Oncology Group performance status of 0 or 1.

  6. Adequate organ/bone marrow function.

  7. Additional inclusion criteria for endometrial cancer cohort:

    1. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair status: small cell/neuroendocrine tumors are not allowed even if mixed histology.

    2. Documented disease progression after having received ≥1 line of therapy (no more than 3), including platinum-based chemotherapy (PBC)-containing systemic treatment and an anti-PD-(L)1 therapy containing regimen (combined or sequential) in the advanced/metastatic setting.

      • Neo-adjuvant/adjuvant systemic therapies are counted as 1 line of therapy if there was progression or recurrence within 1 year from the final dose.
      • Prior hormonal therapy is not counted as a line of therapy in regard to the maximum allowed lines of treatment.

  8. Additional inclusion criterion for non-HGSOC cohort:

    1. Pathologically or cytologically documented unresectable or metastatic CCOC, low-grade endometrioid (Grade2 or lower), low-grade serous (Grade2 or lower), or mucinous OVC, from ovary, fallopian tube or peritoneum origin that was previously treated with at least 1 prior line of therapy.

      • Neo-adjuvant/adjuvant systemic therapies are counted as 1 line of therapy if there was progression or recurrence within 1 year from the final dose.

    2. In Stage 3 only, participants with pathologically or cytologically documented unresectable or metastatic CCOC can be enrolled. Prior line of therapy requirements remains unchanged.

Participants who meet any of the following criteria will be disqualified from entering the trial:

  1. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis.
  2. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event (e.g., intestinal ischemia).
  3. Uncontrolled or significant cardiovascular disease as specified in the protocol.
  4. Has any history of (noninfectious) interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  5. Clinically severe pulmonary compromise.
  6. Chronic steroid treatment (greater than [>]10 mg/day prednisone [or equivalent]) with exceptions as noted in the protocol.
  7. History of other active malignancy within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate >90%) and treated with expected curative outcome.
  8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0, Grade less than or equal to (≤)1 or baseline.
  9. Prior exposure to other CDH6-targeted agents or an antibody drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, datopotamab deruxtecan).
  10. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
  11. Has active or uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection

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: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Endometrial Cancer Cohort

Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W).
의약품: Raludotatug deruxtecan

IV administration Q3W

다른 이름들:
  • R-DXd
실험적: Cervical Cancer Cohort

Participants with cervical cancer who will receive R-DXd administered intravenously Q3W.
의약품: Raludotatug deruxtecan

IV administration Q3W

다른 이름들:
  • R-DXd
실험적: Non-high-grade Serous Ovarian Cancer

Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W.
의약품: Raludotatug deruxtecan

IV administration Q3W

다른 이름들:
  • R-DXd
실험적: Urothelial Cancer Cohort

Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W.
의약품: Raludotatug deruxtecan

IV administration Q3W

다른 이름들:
  • R-DXd
실험적: Clear Cell Renal Carcinoma (ccRCC) Cohort

Participants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W.
의약품: Raludotatug deruxtecan

IV administration Q3W

다른 이름들:
  • R-DXd

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC)
기간: Baseline up to 48 months

Objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 criteria.
Baseline up to 48 months
Disease Control Rate (DCR) as Assessed by the Investigator (ccRCC Cohort Only)
기간: Baseline up to 48 months

DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (maintained for ≥5 weeks) according to RECIST version 1.1.
Baseline up to 48 months
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (All Cohorts)
기간: Baseline up to 48 months
Baseline up to 48 months

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-free Survival (PFS) as Assessed by the Investigator
기간: Baseline up to 48 months

PFS is defined as the time interval from the start date of trial intervention to the date of radiographic disease progression according to RECIST version 1.1 criteria or death due to any cause, whichever comes first.
Baseline up to 48 months
Duration of Response (DoR) as Assessed by the Investigator
기간: Baseline up to 48 months

DoR is defined as the time from the date of the first documentation of objective response (CR or PR) that is subsequently confirmed to the date of the first documentation of radiographic disease progression according to RECIST version 1.1 criteria or death due to any cause, whichever occurs first.
Baseline up to 48 months
Time to Response (TTR) as Assessed by the Investigator
기간: Baseline up to 48 months

TTR is defined as the time from the start date of trial intervention to the date of the first documentation of response (CR or PR) that is subsequently confirmed. TTR will be calculated for confirmed responders only.
Baseline up to 48 months
Objective Response Rate as Assessed by the Investigator (ccRCC Cohort Only)
기간: Baseline up to 48 months

ORR is defined as the proportion of participants with a BOR of confirmed CR or PR according to RECIST version 1.1 criteria.
Baseline up to 48 months
Disease Control Rate (DCR) as Assessed by the Investigator (All Cohorts Except ccRCC Cohort)
기간: Baseline up to 48 months

DCR is defined as proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (maintained for ≥5 weeks) according to RECIST version 1.1.
Baseline up to 48 months
Pharmacokinetic Parameter Maximum Concentration (Cmax) of R-DXd
기간: Cycles 1 and 3 Day 1 predose and end of infusion (EOI), 3 hours (hr), and 5 hr postdose; Cycle 1 Days 8, 15, and 22; Cycle 2 Day 1 predose and EOI postdose; Cycle 4 (and every 2 cycles thereafter) predose, up to 48 months (each cycle is 21 days)
Cycles 1 and 3 Day 1 predose and end of infusion (EOI), 3 hours (hr), and 5 hr postdose; Cycle 1 Days 8, 15, and 22; Cycle 2 Day 1 predose and EOI postdose; Cycle 4 (and every 2 cycles thereafter) predose, up to 48 months (each cycle is 21 days)
The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have a Treatment-emergent ADA
기간: Baseline up to 48 months
Baseline up to 48 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Daiichi Sankyo

협력자

Merck Sharp & Dohme LLC

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)

2025년 1월 6일

기본 완료 (추정된)

2029년 12월 30일

연구 완료 (추정된)

2029년 12월 30일

연구 등록 날짜

최초 제출

2024년 10월 25일

QC 기준을 충족하는 최초 제출

2024년 10월 25일

처음 게시됨 (실제)

2024년 10월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 21일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • DS6000-126
  • 2024-513307-13-00 (씨티스)
  • jRCT2031240486 (레지스트리 식별자: jRCT)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD 공유 기간

Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD 공유 액세스 기준

Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • 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. .

구독하다