A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)

September 21, 2026 updated by: Daiichi Sankyo

REJOICE-PanTumor01: A Phase 2, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants With Advanced/Metastatic Solid Tumors

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]).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
335

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven Gynaec onco
      • Wilrijk, Belgium, 2610
        • ZAS Sint-Augustinus
  • China
      • Changsha, China, 410013
        • Hunan Cancer Hospital
      • Shanghai, China, 200000
        • Shanghai Cancer center
  • Denmark
      • Copenhagen, Denmark, 2100
        • Herlev og Gentofte Hosp
  • France
      • Caen, France, 14000
        • François Baclesse Center
      • Dijon, France, 21079
        • Centre Georges-François Leclerc
      • Lille, France, 59 000
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Paris, France, 75012
        • Grp Hsp Diac Croix Saint Simon
      • Plérin, France, 22190
        • Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie
      • Saint-Herblain, France, 44805
        • Ico - Site René Gauducheau
      • Toulouse, France, 31100
        • Institut Claudius Regaud
      • Villejuif, France, 94800
        • Gustave Roussy
  • Italy
      • Catania, Italy, 95126
        • AO per lEmergenza Cannizzaro
      • Genova, Italy, 16132
        • Irccs Ospedale San Martino
      • Meldola, Italy, 47014
        • IRCCS Dino Amadori - IRST
      • Milan, Italy, 20132
        • IRCCS San Raffaele
      • Milan, Italy, 40121
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Naples, Italy, 80131
        • Federico II Hospital
      • Terni, Italy, 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
  • South Korea
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario de A Coruña
      • Barcelona, Spain, 08035
        • Vall d'Hebron University Hospital
      • Barcelona, Spain, 08041
        • Hospital de Sant Pau
      • Madrid, Spain, 28041
        • Hospital 12 Octubre
      • Madrid, Spain, 28027
        • The Clínica Universidad de Navarra Madrid
      • Madrid, Spain, 28033
        • Md Anderson Cancer Centre
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
  • United States
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northside Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center Michigan Medicine
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Astera Cancer Care
    • New York
      • Albany, New York, United States, 12208
        • Women's Cancer Care Associates
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Westbury, New York, United States, 11590
        • Clinical Research Alliance
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center and Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Endometrial Cancer Cohort

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

IV administration Q3W

Other Names:
  • R-DXd
Experimental: Cervical Cancer Cohort

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

IV administration Q3W

Other Names:
  • R-DXd
Experimental: Non-high-grade Serous Ovarian Cancer

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

IV administration Q3W

Other Names:
  • R-DXd
Experimental: Urothelial Cancer Cohort

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

IV administration Q3W

Other Names:
  • R-DXd
Experimental: Clear Cell Renal Carcinoma (ccRCC) Cohort

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

IV administration Q3W

Other Names:
  • R-DXd

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC)
Time Frame: 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)
Time Frame: 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)
Time Frame: Baseline up to 48 months
Baseline up to 48 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) as Assessed by the Investigator
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: Baseline up to 48 months
Baseline up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS6000-126
  • 2024-513307-13-00 (Ctis)
  • jRCT2031240486 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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