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Advanced Solid TumorPhase 2NCT06660654

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

A Phase 2 study testing Raludotatug deruxtecan in people with Advanced Solid Tumor and Metastatic Solid Tumors, run by Daiichi Sankyo at 48 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Metastatic Solid Tumors
What is being tested?
Raludotatug deruxtecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
335 participants
Where
48 sitesin 9 countries
Study dates
6 Jan 2025to 30 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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:
  8. 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.
  9. 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.
  1. Additional inclusion criterion for non-HGSOC cohort:
  2. 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.
  1. 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

Trial locations and contacts

48 sites in 9 countries.

48 sites in 9 countries

France9 sites
  • François Baclesse Center

    Caen, 14000

  • Centre Georges-François Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59 000

  • Centre Leon Berard

    Lyon, 69008

  • Grp Hsp Diac Croix Saint Simon

    Paris, 75012

  • Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie

    Plérin, 22190

  • Ico - Site René Gauducheau

    Saint-Herblain, 44805

  • Institut Claudius Regaud

    Toulouse, 31100

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

United States8 sites
  • Women's Cancer Care Associates

    Albany, New York, 12208

  • University of Michigan Comprehensive Cancer Center Michigan Medicine

    Ann Arbor, Michigan, 48109

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • West Cancer Center and Research Institute

    Germantown, Tennessee, 38138

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Northside Hospital

    Marietta, Georgia, 30060

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Clinical Research Alliance

    Westbury, New York, 11590

Other trials in United States

Japan8 sites
  • Hyogo Cancer Center

    Akashi, 13-70

  • National Cancer Center Hospital

    Chūōku, 104-0045

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Saitama Medical University International Medical Center

    Hidaka, 1397-1

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • The Cancer Institute Hospital of Jfcr

    Kōtoku

  • Aichi Cancer Centre

    Nagoya, 464-8681

  • Osaka International Cancer Institute

    Osaka, 541-8567

Other trials in Japan

Italy7 sites
  • AO per lEmergenza Cannizzaro

    Catania, 95126

  • Irccs Ospedale San Martino

    Genova, 16132

  • IRCCS Dino Amadori - IRST

    Meldola, 47014

  • IRCCS San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 40121

  • Federico II Hospital

    Naples, 80131

  • Azienda Ospedaliera S Maria

    Terni, 05100

Other trials in Italy

Spain7 sites
  • Hospital Universitario de A Coruña

    A Coruña, 15006

  • Vall d'Hebron University Hospital

    Barcelona, 08035

  • Hospital de Sant Pau

    Barcelona, 08041

  • The Clínica Universidad de Navarra Madrid

    Madrid, 28027

  • Md Anderson Cancer Centre

    Madrid, 28033

  • Hospital 12 Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

Other trials in Spain

South Korea4 sites
  • National Cancer Center

    Goyang-si, 10408

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Belgium2 sites
  • UZ Leuven Gynaec onco

    Leuven, 3000

  • ZAS Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

China2 sites
  • Hunan Cancer Hospital

    Changsha, 410013

  • Shanghai Cancer center

    Shanghai, 200000

Other trials in China

Denmark1 site
  • Herlev og Gentofte Hosp

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: 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]).

Read the 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.

Being tested
Raludotatug deruxtecan
Keywords
Advanced/metastatic solid tumors, Raludotatug Deruxtecan, R-DXd, DS-6000

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Raludotatug deruxtecanDrug

    Also called R-DXd

    IV administration Q3W

Study groups in NCT06660654
Study groupRoleWhat they receive
Endometrial Cancer CohortExperimentalParticipants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W).
Receives: Drug: Raludotatug deruxtecan
Cervical Cancer CohortExperimentalParticipants with cervical cancer who will receive R-DXd administered intravenously Q3W.
Receives: Drug: Raludotatug deruxtecan
Non-high-grade Serous Ovarian CancerExperimentalParticipants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W.
Receives: Drug: Raludotatug deruxtecan
Urothelial Cancer CohortExperimentalParticipants with urothelial cancer who will receive R-DXd administered intravenously Q3W.
Receives: Drug: Raludotatug deruxtecan
Clear Cell Renal Carcinoma (ccRCC) CohortExperimentalParticipants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W.
Receives: Drug: Raludotatug deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC)

    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.

    Measured: Baseline up to 48 months

  2. Disease Control Rate (DCR) as Assessed by the Investigator (ccRCC Cohort Only)

    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.

    Measured: Baseline up to 48 months

  3. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) (All Cohorts)

    Measured: Baseline up to 48 months

Secondary outcomes (7)
  1. Progression-free Survival (PFS) as Assessed by the Investigator

    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.

    Measured: Baseline up to 48 months

  2. Duration of Response (DoR) as Assessed by the Investigator

    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.

    Measured: Baseline up to 48 months

  3. Time to Response (TTR) as Assessed by the Investigator

    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.

    Measured: Baseline up to 48 months

  4. Objective Response Rate as Assessed by the Investigator (ccRCC Cohort Only)

    ORR is defined as the proportion of participants with a BOR of confirmed CR or PR according to RECIST version 1.1 criteria.

    Measured: Baseline up to 48 months

  5. Disease Control Rate (DCR) as Assessed by the Investigator (All Cohorts Except ccRCC Cohort)

    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.

    Measured: Baseline up to 48 months

  6. Pharmacokinetic Parameter Maximum Concentration (Cmax) of R-DXd

    Measured: 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)

  7. The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have a Treatment-emergent ADA

    Measured: Baseline up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start6 Jan 2025
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
335 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660654
Sponsor's protocol ID
DS6000-126
Other IDs
2024-513307-13-00, jRCT2031240486
Status last verified
Sep 2026
First submitted
25 Oct 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Raludotatug deruxtecan in people with Advanced Solid Tumor and Metastatic Solid Tumors, run by Daiichi Sankyo at 48 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in France, United States, Japan, Italy, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate as Assessed by the Investigator (All Cohorts Except ccRCC) (time frame: Baseline up to 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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