A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
NCT ID: NCT06660654
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-01-06
2027-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endometrial Cancer Cohort
Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W).
Raludotatug deruxtecan
IV administration Q3W
Cervical Cancer Cohort
Participants with cervical cancer who will receive R-DXd administered intravenously Q3W.
Raludotatug deruxtecan
IV administration Q3W
Non-high-grade Serous Ovarian Cancer
Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W.
Raludotatug deruxtecan
IV administration Q3W
Urothelial Cancer Cohort
Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W.
Raludotatug deruxtecan
IV administration Q3W
Clear Cell Renal Carcinoma (ccRCC) Cohort
Participants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W.
Raludotatug deruxtecan
IV administration Q3W
Interventions
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Raludotatug deruxtecan
IV administration Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must have at least 1 lesion, not previously irradiated, 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.
1. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair status.
2. Documented disease progression after having received ≥1 line of therapy (no more than 3), including PBC-containing systemic treatment and an anti-PD-1 therapy containing regimen (combined or sequential) in the advanced/metastatic setting.
1. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.
2. Disease progression after having received ≥1 prior line of therapy that includes systemic therapy in the advanced or metastatic setting.
8. Additional inclusion criterion for non-HGSOC cohort
a. Pathologically or cytologically documented unresectable or metastatic CCOC, low grade endometrioid, low-grade serous, or mucinous OVC that was previously treated with at least 1 prior line of therapy.
1. Pathologically or cytologically documented unresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant.
2. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting.
10. Additional inclusion criterion for the ccRCC cohort a. Pathologically or cytologically documented unresectable or metastatic ccRCC that was previously treated with no more than 3 prior systemic regimens for locally advanced or metastatic RCC, including both a PD-(L)1 checkpoint inhibitor and a VEGF-TKI in sequence or in combination.
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.
3. Uncontrolled or significant cardiovascular disease as specified in the protocol.
4. Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, 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 (\>10 mg/day) 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 NCI-CTCAE Version 5.0, Grade ≤1 or baseline.
9. Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan, datopotamab deruxtecan).
10. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
11. Has active or uncontrolled HIV, HBV, or HCV infection.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Northside Hospital
Marietta, Georgia, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Women's Cancer Care Associates
Albany, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Clinical Research Alliance
Westbury, New York, United States
West Cancer Center and Research Institute
Germantown, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
UZ Leuven Gynaec onco
Leuven, , Belgium
ZAS Sint-Augustinus
Wilrijk, , Belgium
Hunan Cancer Hospital
Changsha, , China
Shanghai Cancer center
Shanghai, , China
Herlev og Gentofte Hosp
Copenhagen, , Denmark
François Baclesse Center
Caen, , France
Centre Georges-François Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Grp Hsp Diac Croix Saint Simon
Paris, , France
Cario - Centre Armoricain de Radiothérapie, Imagerie Médicale Et Oncologie
Plérin, , France
Ico - Site René Gauducheau
Saint-Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Gustave Roussy
Villejuif, , France
AO per lEmergenza Cannizzaro
Catania, , Italy
Irccs Ospedale San Martino
Genova, , Italy
IRCCS Dino Amadori - IRST
Meldola, , Italy
IRCCS San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Federico II Hospital
Naples, , Italy
Azienda Ospedaliera S Maria
Terni, , Italy
Hyogo Cancer Center
Akashi, , Japan
National Cancer Center Hospital
Chūōku, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Saitama Medical University International Medical Center
Hidaka, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, , Japan
Aichi Cancer Centre
Nagoya, , Japan
Osaka International Cancer Institute
Osaka, , Japan
National Cancer Center
Goyang-si, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario de A Coruña
A Coruña, , Spain
Vall d'Hebron University Hospital
Barcelona, , Spain
Hospital de Sant Pau
Barcelona, , Spain
The Clínica Universidad de Navarra Madrid
Madrid, , Spain
Md Anderson Cancer Centre
Madrid, , Spain
Hospital 12 Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Other Identifiers
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2024-513307-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
DS6000-126
Identifier Type: -
Identifier Source: org_study_id
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