Clinical trial • Phase II • Oncology
RALUDOTATUG DERUXTECAN for Advanced/metastatic solid tumors | Endometrial cancer | Cervical cancer | Ovarian cancer | Urothelial carcinoma | Clear cell renal cell carcinoma
Phase II trial of RALUDOTATUG DERUXTECAN for Advanced/metastatic solid tumors | Endometrial cancer | Cervical cancer | Ovarian cancer | Urothelial carcino…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced/metastatic solid tumors | Endometrial cancer | Cervical cancer | Ovarian cancer | Urothelial carcinoma | Clear cell renal cell carcinoma
- Trial Stage
- Phase II
- Drug Modality
- ADC|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 26-11-2024
- First CTIS Authorization Date
- 24-03-2025
Trial design
open-label, none/not specified-controlled Phase II trial in Belgium, Denmark, Spain and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 127
Eligibility
Recruits 127 Vulnerable population selected. Participants are adults (≥18 years) and consent is obtained from participants; local regulatory requirements apply if legal age of consent is >18. Participant information and consent forms (including pregnancy-specific ICFs) are available in multiple languages (English, French, Dutch, Italian, Spanish). No specific assent procedures for minors are provided (minors are not eligible)..
- Vulnerable Population
- Vulnerable population selected. Participants are adults (≥18 years) and consent is obtained from participants; local regulatory requirements apply if legal age of consent is >18. Participant information and consent forms (including pregnancy-specific ICFs) are available in multiple languages (English, French, Dutch, Italian, Spanish). No specific assent procedures for minors are provided (minors are not eligible).
Inclusion criteria
- {"criterion_text":"- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.\n- 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.\n- 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.\n- Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment.\n- Participants must have progressed radiologically on or after their most recent line of systemic therapy.\n- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n- Additional inclusion criteria for endometrial cancer cohort a. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair status. b. 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.\n- Additional inclusion criteria for cervical cancer cohort a. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix. b. Disease progression after having received ≥1 prior line of therapy that includes systemic therapy in the advanced or metastatic setting.\n- Additional inclusion criterion for non-HGSOC cohort a. Pathologically or cytologically documented unresectable or metastatic CCOC, lowgrade endometrioid, low-grade serous, or mucinous OVC that was previously treated with at least 1 prior line of therapy.\n- Additional inclusion criteria for urothelial cancer cohort a. 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. b. 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."}
Exclusion criteria
- {"criterion_text":"- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis.\n- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n- Has active or uncontrolled HIV, HBV or HCV infection.\n- Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n- Uncontrolled or significant cardiovascular disease as specified in the protocol.\n- 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.\n- Clinically severe pulmonary compromise\n- Chronic steroid treatment (>10 mg/day) with exceptions as noted in the protocol.\n- 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 .\n- 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.\n- 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)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- For all cohorts except ccRCC: ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR according to RECIST version 1.1 criteria.For 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. Incidence of TEAEs, SAEs, AESIs","definition_or_measurement_approach":"ORR (all cohorts except ccRCC): proportion with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1 (investigator assessment). DCR (ccRCC cohort): proportion with BOR of confirmed CR, confirmed PR, or stable disease maintained for ≥5 weeks per RECIST v1.1. Safety endpoints measured as incidence of TEAEs, SAEs, AESIs."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 127
- Recruitment Window Months
- 29
- Consent Approach
- Informed consent is provided by participants (adults ≥18 years). The protocol states: 'Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.' Subject information and consent forms are available in multiple languages (English, French, Dutch, Italian, Spanish) and include specific pregnancy information forms and pregnancy ICFs; no assent procedures for minors are provided as minors are not eligible.
Methods
- Doctor-to-Patient letter (K2) distributed by treating physicians; country-specific versions available (e.g. BE, DK, ES, IT, FR).
- Physician Referral Letter (K2) to enable physician-to-physician referrals.
- Recruitment and consent procedure documents (K1) provided to sites to standardise site-level recruitment and consent.
- Site engagement platform (Teckro Limited) used for site engagement and communications.
- Patient contact by email (L2_Patient Emails) — patient-facing electronic communications materials available (country-specific).
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 73
Belgium
- Earliest CTIS Part Ii Submission Date
- 25-02-2025
- Latest Decision Or Authorization Date
- 29-08-2025
- Processing Time Days
- 185
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- UZ Leuven
- Department Name
- Gynecological Oncology
- Principal Investigator Name
- Toon Van Gorp
- Principal Investigator Email
- toon.vangorp@uzleuven.be
- Contact Person Name
- Toon Van Gorp
- Contact Person Email
- toon.vangorp@uzleuven.be
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- Medical Oncology
- Principal Investigator Name
- Thomas van Cann
- Principal Investigator Email
- thomas.vancann@zas.be
- Contact Person Name
- Thomas van Cann
- Contact Person Email
- thomas.vancann@zas.be
- Site Name
- Institut Jules Bordet
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laura Polastro
- Principal Investigator Email
- laura.polastro@hubruxelles.be
- Contact Person Name
- Laura Polastro
- Contact Person Email
- laura.polastro@hubruxelles.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 28-02-2025
- Latest Decision Or Authorization Date
- 29-08-2025
- Processing Time Days
- 182
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Oncology
- Principal Investigator Name
- Rikke Løvendahl Eefsen
- Principal Investigator Email
- rikke.helene.loevendahl.eefsen@regionh.dk
- Contact Person Name
- Rikke Løvendahl Eefsen
- Contact Person Email
- rikke.helene.loevendahl.eefsen@regionh.dk
- Site Name
- Rigshospitalet
- Department Name
- Oncology
- Principal Investigator Name
- Kristoffer Staal Rohrberg
- Principal Investigator Email
- Kristoffer.Staal.Rohrberg@regionh.dk
- Contact Person Name
- Kristoffer Staal Rohrberg
- Contact Person Email
- Kristoffer.Staal.Rohrberg@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 10-03-2025
- Latest Decision Or Authorization Date
- 05-11-2025
- Processing Time Days
- 240
- Number Of Sites
- 8
- Number Of Participants
- 19
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Georgia Anguera Palacios
- Principal Investigator Email
- ganguera@santpau.cat
- Contact Person Name
- Georgia Anguera Palacios
- Contact Person Email
- ganguera@santpau.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Daniel Castellano Gauna
- Principal Investigator Email
- cdanicas@gmail.com
- Contact Person Name
- Daniel Castellano Gauna
- Contact Person Email
- cdanicas@gmail.com
- Site Name
- MD Anderson Cancer Center
- Department Name
- Oncology
- Principal Investigator Name
- Enrique Grande Pulido
- Principal Investigator Email
- egrande@mdanderson.es
- Contact Person Name
- Enrique Grande Pulido
- Contact Person Email
- egrande@mdanderson.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Principal Investigator Name
- Maria Quindos Varela
- Principal Investigator Email
- maria.quindos.varela@sergas.es
- Contact Person Name
- Maria Quindos Varela
- Contact Person Email
- maria.quindos.varela@sergas.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Antonio Gonzalez Martin
- Principal Investigator Email
- agonzalezma@unav.es
- Contact Person Name
- Antonio Gonzalez Martin
- Contact Person Email
- agonzalezma@unav.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Begoña Pérez Valderrama
- Principal Investigator Email
- bpvalderrama@gmail.com
- Contact Person Name
- Begoña Pérez Valderrama
- Contact Person Email
- bpvalderrama@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Maria Jose Bermejo Perez
- Principal Investigator Email
- cheberpe@gmail.com
- Contact Person Name
- Maria Jose Bermejo Perez
- Contact Person Email
- cheberpe@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Elena Garralda Cabanas
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Italy
- Earliest CTIS Part Ii Submission Date
- 31-10-2024
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 434
- Number Of Sites
- 8
- Number Of Participants
- 21
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Andrea Necchi
- Principal Investigator Email
- necchi.andrea@hsr.it
- Contact Person Name
- Andrea Necchi
- Contact Person Email
- necchi.andrea@hsr.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Emilio Giunta
- Principal Investigator Email
- emilio.giunta@irst.emr.it
- Contact Person Name
- Emilio Giunta
- Contact Person Email
- emilio.giunta@irst.emr.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Medical Oncology
- Principal Investigator Name
- Luigi Formisano
- Principal Investigator Email
- luigi.formisano1@unina.it
- Contact Person Name
- Luigi Formisano
- Contact Person Email
- luigi.formisano1@unina.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology and Haematology
- Principal Investigator Name
- Giuseppe Procopio
- Principal Investigator Email
- Giuseppe.Procopio@istitutotumori.mi.it
- Contact Person Name
- Giuseppe Procopio
- Contact Person Email
- Giuseppe.Procopio@istitutotumori.mi.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Medical Oncology
- Principal Investigator Name
- Giuseppe Fornarini
- Principal Investigator Email
- giuseppe.fornarini@hsanmartino.it
- Contact Person Name
- Giuseppe Fornarini
- Contact Person Email
- giuseppe.fornarini@hsanmartino.it
- Site Name
- Azienda Ospedaliera S Maria Di Terni
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sergio Bracarda
- Principal Investigator Email
- s.bracarda@aospterni.it
- Contact Person Name
- Sergio Bracarda
- Contact Person Email
- s.bracarda@aospterni.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- U.O. Oncology
- Principal Investigator Name
- Gianluca Masi
- Principal Investigator Email
- gianlucamasi72@gmail.com
- Contact Person Name
- Gianluca Masi
- Contact Person Email
- gianlucamasi72@gmail.com
- Site Name
- Azienda Ospedaliera Per L'Emergenza Cannizzaro
- Department Name
- Medical Oncology
- Principal Investigator Name
- Giuseppa Scandurra
- Principal Investigator Email
- giuseppascandurra@pec.ordinemedct.it
- Contact Person Name
- Giuseppa Scandurra
- Contact Person Email
- giuseppascandurra@pec.ordinemedct.it
France
- Earliest CTIS Part Ii Submission Date
- 23-01-2025
- Latest Decision Or Authorization Date
- 07-01-2026
- Processing Time Days
- 349
- Number Of Sites
- 9
- Number Of Participants
- 21
Sites
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- ONCOLOGIE OPTION MEDICALE
- Principal Investigator Name
- Jean-Sebastien FRENEL
- Principal Investigator Email
- jean-sebastien.frenel@ico.unicancer.fr
- Contact Person Name
- Jean-Sebastien FRENEL
- Contact Person Email
- jean-sebastien.frenel@ico.unicancer.fr
- Site Name
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Department Name
- ONCOLOGIE OPTION MEDICALE
- Principal Investigator Name
- Antoine ANGELERGUES
- Principal Investigator Email
- aangelergues@hopital-dcss.org
- Contact Person Name
- Antoine ANGELERGUES
- Contact Person Email
- aangelergues@hopital-dcss.org
- Site Name
- Oncopole Claudius Regaud
- Department Name
- ONCOLOGIE OPTION MEDICALE
- Principal Investigator Name
- Carlos Alberto GOMEZ-ROCA
- Principal Investigator Email
- gomez-roca.carlos@iuct-oncopole.fr
- Contact Person Name
- Carlos Alberto GOMEZ-ROCA
- Contact Person Email
- gomez-roca.carlos@iuct-oncopole.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- ONCOLOGIE OPTION MEDICALE
- Principal Investigator Name
- Florence JOLY
- Principal Investigator Email
- f.joly@baclesse.unicancer.fr
- Contact Person Name
- Florence JOLY
- Contact Person Email
- f.joly@baclesse.unicancer.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- MEDECINE INTERNE
- Principal Investigator Name
- François GHIRINGHELLI
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- François GHIRINGHELLI
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- ONCOLOGIE OPTION MEDICALE
- Principal Investigator Name
- Cyril ABDEDDAIM
- Principal Investigator Email
- c-abdeddaim@o-lambret.fr
- Contact Person Name
- Cyril ABDEDDAIM
- Contact Person Email
- c-abdeddaim@o-lambret.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- ONCOLOGIE OPTION MEDICALE
- Principal Investigator Name
- Laurence ALBIGES
- Principal Investigator Email
- laurence.albiges@gustaveroussy.fr
- Contact Person Name
- Laurence ALBIGES
- Contact Person Email
- laurence.albiges@gustaveroussy.fr
- Site Name
- CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
- Department Name
- ONCOLOGIE OPTION MEDICALE
- Principal Investigator Name
- Anne-Claire HARDY-BESSARD
- Principal Investigator Email
- ac.hardy@cario-sante.fr
- Contact Person Name
- Anne-Claire HARDY-BESSARD
- Contact Person Email
- ac.hardy@cario-sante.fr
- Site Name
- Centre Leon Berard
- Department Name
- ONCOLOGIE OPTION MEDICALE
- Principal Investigator Name
- Aude FLECHON
- Principal Investigator Email
- aude.flechon@lyon.unicancer.fr
- Contact Person Name
- Aude FLECHON
- Contact Person Email
- aude.flechon@lyon.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Daiichi Sankyo Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- WCG Clinical Inc.
- Responsibilities
- sponsorDuties codes: ["8"]
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties codes: ["4"]
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: ["1","12","2","5"]
- Name
- Suvoda LLC
- Responsibilities
- sponsorDuties codes: ["3"]
- Name
- Bioclinica Inc.
- Responsibilities
- sponsorDuties code: 15; value: Independent central imaging reviewer; ILD Adjudication Committee
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties code: 7
Third parties
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: [\"8\"]","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Site Engagement Platform (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code: 15; value: Independent central imaging reviewer; ILD Adjudication Committee","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [\"1\",\"12\",\"2\",\"5\"]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Bioservices Inc.","duties_or_roles":"sponsorDuties value: Long term storage (code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Raludotatug Deruxtecan
- Active Substance
- RALUDOTATUG DERUXTECAN
- Modality
- ADC|Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- prodAuthStatus: 1
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