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Clinical Trials in Spain / NCT06660654
Active, not recruiting Phase 2

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

NCT06660654 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2025-01-06
Last updated
2026-09-24

Condition(s) studied

Advanced Solid TumorMetastatic Solid Tumors

Investigational drug(s) / intervention(s)

Raludotatug deruxtecan →

Raludotatug deruxtecan: IV administration Q3W

Study 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 non-high-grade serous ovarian cancer) and genitourinary cancers (urothelial cancer and clear cell renal cell carcinoma \[ccRCC\]).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
Northside Hospital Marietta Georgia
University of Michigan Comprehensive Cancer Center Michigan Medicine Ann Arbor Michigan
Astera Cancer Care East Brunswick New Jersey
Women's Cancer Care Associates Albany New York
Memorial Sloan-Kettering Cancer Center New York New York
Clinical Research Alliance Westbury New York
West Cancer Center and Research Institute Germantown Tennessee
The University of Texas MD Anderson Cancer Center Houston Texas
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

+ 8 more sites — see the full list on the official registry below.

More Daiichi Sankyo trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06660654 on ClinicalTrials.gov ↗ ← All trials in Spain