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.
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:
- Adults greater than or equal to ( ≥) 18 years of age on the day of signing the informed consent form (ICF).
- 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.
- Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment.
- Participants must have progressed radiologically on or after their most recent line of systemic therapy.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ/bone marrow function.
- Additional inclusion criteria for endometrial cancer cohort:
- 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.
- 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.
- Additional inclusion criterion for non-HGSOC cohort:
- 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.
- 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:
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis.
- 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).
- Uncontrolled or significant cardiovascular disease as specified in the protocol.
- 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.
- Clinically severe pulmonary compromise.
- Chronic steroid treatment (greater than [>]10 mg/day prednisone [or equivalent]) with exceptions as noted in the protocol.
- 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.
- 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.
- 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).
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- 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
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
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
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
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
South Korea4 sites
National Cancer Center
Goyang-si, 10408
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Belgium2 sites
UZ Leuven Gynaec onco
Leuven, 3000
ZAS Sint-Augustinus
Wilrijk, 2610
China2 sites
Hunan Cancer Hospital
Changsha, 410013
Shanghai Cancer center
Shanghai, 200000
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.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumors
- 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 group | Role | What they receive |
|---|---|---|
| Endometrial Cancer Cohort | Experimental | Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W). Receives: Drug: Raludotatug deruxtecan |
| Cervical Cancer Cohort | Experimental | Participants with cervical cancer who will receive R-DXd administered intravenously Q3W. Receives: Drug: Raludotatug deruxtecan |
| Non-high-grade Serous Ovarian Cancer | Experimental | Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W. Receives: Drug: Raludotatug deruxtecan |
| Urothelial Cancer Cohort | Experimental | Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W. Receives: Drug: Raludotatug deruxtecan |
| Clear Cell Renal Carcinoma (ccRCC) Cohort | Experimental | Participants 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.
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
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
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)
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
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
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
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
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
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)
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.
- First posted28 Oct 2024
- Study start6 Jan 2025
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
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/
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06660654
- Acronym / sponsor ID
- DS6000-126
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumors
- Keywords
- Advanced/metastatic solid tumors, Raludotatug Deruxtecan, R-DXd, DS-6000
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 335 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Endometrial Cancer Cohort | Experimental | Drug: Raludotatug deruxtecanParticipants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W). |
| Cervical Cancer Cohort | Experimental | Drug: Raludotatug deruxtecanParticipants with cervical cancer who will receive R-DXd administered intravenously Q3W. |
| Non-high-grade Serous Ovarian Cancer | Experimental | Drug: Raludotatug deruxtecanParticipants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W. |
| Urothelial Cancer Cohort | Experimental | Drug: Raludotatug deruxtecanParticipants with urothelial cancer who will receive R-DXd administered intravenously Q3W. |
| Clear Cell Renal Carcinoma (ccRCC) Cohort | Experimental | Drug: Raludotatug deruxtecanParticipants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raludotatug deruxtecanAlso: R-DXdIV administration Q3W | Drug | Cervical Cancer Cohort, Clear Cell Renal Carcinoma (ccRCC) Cohort, Endometrial Cancer Cohort, Non-high-grade Serous Ovarian Cancer, Urothelial Cancer Cohort |
Primary outcome
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.
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.
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
7 secondary outcomes
Progression-free Survival (PFS) as Assessed by the Investigator
Time frame: Baseline up to 48 months
Duration of Response (DoR) as Assessed by the Investigator
Time frame: Baseline up to 48 months
Time to Response (TTR) as Assessed by the Investigator
Time frame: Baseline up to 48 months
Objective Response Rate as Assessed by the Investigator (ccRCC Cohort Only)
Time frame: 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
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 9 countries: see every site and its status.
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.