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Een onderzoek naar Raludotatug Deruxtecan bij deelnemers met gevorderde/metastatische solide tumoren (REJOICE-PanTumor01)

21 september 2026 bijgewerkt door: Daiichi Sankyo

REJOICE-PanTumor01: een fase 2, multicenter, open-label, pan-tumoronderzoek om de werkzaamheid en veiligheid van Raludotatug Deruxtecan (R-DXd) te evalueren bij deelnemers met gevorderde/gemetastaseerde solide tumoren

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]).

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

335

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Endometrial Cancer Cohort

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

IV administration Q3W

Andere namen:
  • R-DXd
Experimenteel: Cervical Cancer Cohort

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

IV administration Q3W

Andere namen:
  • R-DXd
Experimenteel: Non-high-grade Serous Ovarian Cancer

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

IV administration Q3W

Andere namen:
  • R-DXd
Experimenteel: Urothelial Cancer Cohort

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

IV administration Q3W

Andere namen:
  • R-DXd
Experimenteel: Clear Cell Renal Carcinoma (ccRCC) Cohort

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

IV administration Q3W

Andere namen:
  • R-DXd

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Baseline up to 48 months
Baseline up to 48 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free Survival (PFS) as Assessed by the Investigator
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline up to 48 months
Baseline up to 48 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Daiichi Sankyo

Medewerkers

Merck Sharp & Dohme LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 januari 2025

Primaire voltooiing (Geschat)

30 december 2029

Studie voltooiing (Geschat)

30 december 2029

Studieregistratiedata

Eerst ingediend

25 oktober 2024

Eerst ingediend dat voldeed aan de QC-criteria

25 oktober 2024

Eerst geplaatst (Werkelijk)

28 oktober 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • DS6000-126
  • 2024-513307-13-00 (Ctis)
  • jRCT2031240486 (Register-ID: jRCT)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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