Clinical trial • Phase II/III • Oncology

RALUDOTATUG DERUXTECAN for Platinum-resistant high-grade serous ovarian cancer | High-grade endometrioid ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer

Phase II/III trial of RALUDOTATUG DERUXTECAN for Platinum-resistant high-grade serous ovarian cancer | High-grade endometrioid ovarian cancer | Primary pe…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Platinum-resistant high-grade serous ovarian cancer | High-grade endometrioid ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer
Trial Stage
Phase II/III
Drug Modality
ADC | Small molecule

Key dates

Initial CTIS Submission Date
01-02-2024
First CTIS Authorization Date
23-05-2024

Trial design

Randomised, investigator’s choice chemotherapy comparator arms: paclitaxel (paclitaxel) — concentrate for solution for infusion; dose unit mg/m2 (max daily dose amount listed 80 mg/m2) ; pegylated liposomal doxorubicin (doxorubicin hydrochloride, liposomal) — solution for infusion; dose unit mg/m2 (max daily dose amount listed 40 mg/m2) ; topotecan (topotecan) — powder for concentrate for solution for infusion; dose unit mg/m2 (max daily dose amount listed 4 mg/m2). specific schedule details not specified in the ctis record.-controlled, adaptive Phase II/III trial in France, Germany, Greece and others.

Randomised
Yes
Comparator
Investigator’s choice chemotherapy comparator arms: PACLITAXEL (PACLITAXEL) — concentrate for solution for infusion; dose unit mg/m2 (max daily dose amount listed 80 mg/m2) ; PEGYLATED LIPOSOMAL DOXORUBICIN (DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL) — solution for infusion; dose unit mg/m2 (max daily dose amount listed 40 mg/m2) ; TOPOTECAN (TOPOTECAN) — powder for concentrate for solution for infusion; dose unit mg/m2 (max daily dose amount listed 4 mg/m2). Specific schedule details not specified in the CTIS record.
Adaptive
True — Phase 2 evaluates ORR at each dose level of R-DXd indicating dose-escalation / multiple dose-level evaluation in Part A (Phase 2), followed by Phase 3 randomised comparison vs investigator's choice; adaptive element: dose levels evaluated in Phase 2 prior to Phase 3.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
516

Eligibility

Recruits 516 isVulnerablePopulationSelected is true. Informed consent is required: "Sign and date the informed consent form prior to the start of any study-specific qualification procedures." Participants must be adults (Age ≥18 years). Subject information and informed consent forms are provided (multiple language versions listed in the dossier). No procedures for assent of minors are provided (minors are excluded by Age ≥18)..

Pregnancy Exclusion
Female who is pregnant or breastfeeding or intends to become pregnant during the study
Vulnerable Population
isVulnerablePopulationSelected is true. Informed consent is required: "Sign and date the informed consent form prior to the start of any study-specific qualification procedures." Participants must be adults (Age ≥18 years). Subject information and informed consent forms are provided (multiple language versions listed in the dossier). No procedures for assent of minors are provided (minors are excluded by Age ≥18).

Inclusion criteria

  • {"criterion_text":"- Sign and date the informed consent form prior to the start of any study-specific qualification procedures\n- Eastern Cooperative Oncology Group performance status of 0 or 1\n- Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of study treatment as defined below. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 3 days of initiation of study treatment as appropriate. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to screening laboratory tests.Adequate organ/bone marrow function is defined in inclusion criterion 11 of the protocol.\n- If the participant is a female of childbearing potential, she must have a negative serum pregnancy test within 72 hours or urine test within 24 hours before the first dose of study drug and must be willing to use highly effective birth control upon enrollment, during the Treatment Period, and for at least the time required to eliminate each study treatment after the last dose. Male partners of subjects with childbearing potential should use additional barrier methods of contraception for the durationof same period. The length of time required to continue contraception for each study treatment is listed in inclusion criterion 12 of the protocol.\n- Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least the time required to eliminate each study treatment after the last dose, as described in the inclusion criterion 12 of the protocol.\n- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions\n- For Phase 3 (Part B) only: Participants must be eligible for one of the treatments included in the Investigator's choice of chemotherapy arm\n- Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed\n- Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer\n- For Phase 2 (Part A): Subjects must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent, and performed after treatment with their most recent cancer therapy regimen For Phase 3 (Part B): Subjects must be willing and able to provide most recently collected (within 5 years of signing the ICF) archival tumor samples with sufficient quantity and quality of tissue. Alternatively, if an archival tumor tissue sample is not available, a newly obtained tumor tissue biopsy from at least 1 lesion not previously irradiated and amenable to core needle biopsy must be provided. If a biopsy procedure is required, the subject must have a lesion that can be biopsied at an acceptable clinical risk as judged by the investigator to be eligible for this trial\n- For Phase 2 (Part A): Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy For Phase 3 (Part B): Has received at least 1 but no more than 4 prior systemic lines of anticancer therapy\n- Has platinum-resistant disease. If a subject had only 1 line of platinum therapy, must have received at least 4 cycles of platinum, must have had a best response of not PD, and then progressed between >90 and ≤180 days after the date of the last dose of platinum If a subject had 2 or 4 lines of platinum therapy, must have received at least 2 cycles of platinum and have progressed on or within 180 days after the date of the last dose of platinum Note: Subjects who are primary platinum refractory during front-line treatment (defined as disease that has progressed on or within ≤90 days of the last dose of first line platinum therapy) are excluded.\n- Has had prior poly-ADP ribose polymerase (PARP) inhibitors for participants with documented breast cancer gene mutation (germline and/or somatic), unless the participant is not eligible for treatment with a PARP inhibitor (Not applicable to subjects in the Phase 3 part of the study)\n- If mirvetuximab soravtansine (MIRV) is locally available: has had prior treatment with MIRV for subjects with documented high folate receptor alpha expression, unless the subject is not eligible for treatment with MIRV\n- Has at least 1 measurable lesion evaluated by computed tomography or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per investigator assessment"}

Exclusion criteria

  • {"criterion_text":"- Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC. (Note for Phase 3 [Part B]: seromucinous, low-grade serous carcinoma or ovarian sarcoma, carcinosarcoma and undifferentiated carcinoma are excluded.)\n- Has a history of receiving live-attenuated vaccine (messenger RNA [mRNA] and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention\n- For Phase 3 (Part B) only: Has clinical symptoms or radiographic evidence of intestinal obstruction for the control group\n- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy, at the investigator’s discretion. A minimum of 2 weeks must have elapsed between the end of radiotherapy and randomization and there should be no evidence of progression or need for steroid treatment or anticonvulsants for at least 2 weeks prior to randomization.\n- Any of the following within the past 6 months prior to randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event (eg, intestinal ischemia).\n- Uncontrolled or significant cardiovascular disease as defined in exclusion criterion 5 of the protocol.\n- Has a history of (noninfectious) interstitial lung disease (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 (ie, requiring any supplemental oxygen) resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement or prior pneumonectomy\n- Chronic steroid treatment (>10 mg/day)\n- History of malignancy other than epithelial OVC, primary peritoneal cancer, or fallopian tube cancer within 3 years prior to enrollment\n- 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 Version 5.0 Grade ≤1 or baseline\n- For Phase 2 (Part A): 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 or datopotamab deruxtecan). For Phase 3 (Part B): Prior exposure to other CDH6-targeted agents or an ADC containing a topoisomerase I inhibitor.\n- For Phase 3 (Part B) only: Has ascites or pleural effusions that require repeated drainage (less than 4 weeks between drainages).\n- History of hypersensitivity to any excipients in the R-DXd or any known contraindication to treatment with, including hypersensitivity to, the study drug(s)\n- Has an active or uncontrolled human immunodeficiency virus (HIV) infection . Participants must be tested for HIV viral load during the Screening Period if acceptable by local regulations or institutional review boards Further details provided in exclusion criterion 13 of the protocol.\n- Has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses or active infection, substance abuse) or other factors that, in the investigator's opinion, makes it undesirable for the participant to participate in the study or which would jeopardize compliance with the protocol\n- Has an active or uncontrolled hepatitis B virus (HBV) or hepatitis C infection (HCV). Hepatitis B and Hepatitis C Screening tests are required. Further details provided in exclusion criterion 15 of the protocol.\n- Female who is pregnant or breastfeeding or intends to become pregnant during the study\n- Psychological, social, familial, or geographical factors that would prevent regular follow-up\n- Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participants ; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Phase 2: ORR as assessed by BICR based on RECIST version 1.1 Phase 3: PFS as assessed by BICR based on RECIST version 1.1 or death due to any reason","definition_or_measurement_approach":"Phase 2 primary endpoint: Overall Response Rate (ORR) assessed by Blinded Independent Central Review (BICR) per RECIST v1.1. Phase 3 primary endpoint: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1 or death from any cause."}

Recruitment

Planned Sample Size
516
Recruitment Window Months
72
Consent Approach
Adult participants (Age ≥18) must sign and date an informed consent form prior to any study-specific qualification procedures. Subject information and informed consent forms (SIS/ICF) and supporting materials are provided and available in multiple language versions (examples in the document list include English, French, Greek, Spanish, Czech, Polish, Portuguese, Italian, Finnish). Optional future-research consent materials are also included in the documentation. No assent process for minors is described (minors excluded).

Geography

Total Number Of Sites
57
Total Number Of Participants
344

France

Earliest CTIS Part Ii Submission Date
07-05-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
687
Number Of Sites
12
Number Of Participants
86

Sites

Site Name
Centre Jean Perrin
Department Name
Oncologie médicale
Contact Person Name
Elsa Kalbacher
Site Name
L'Hopital Prive Du Confluent
Department Name
Oncologie médicale
Contact Person Name
Cyriac Blonz
Site Name
Hopital Prive Des Cotes D'armor
Department Name
Oncologie médicale
Contact Person Name
Anne-Claire Hardy-Bessard
Contact Person Email
ac.hardy@cario-sante.fr
Site Name
Centre Leon Berard
Department Name
Oncologie médicale
Contact Person Name
Isabelle Ray-Coquard
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncologie médicale
Contact Person Name
Véronique D'hondt
Site Name
Institut Curie
Department Name
Oncologie médicale
Contact Person Name
Diana Bello Roufai
Contact Person Email
diana.belloroufai@curie.fr
Site Name
Institut Paoli-Calmettes
Department Name
Oncologie médicale
Contact Person Name
Renaud Sabatier
Contact Person Email
sabatierr@ipc.unicancer.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie médicale
Contact Person Name
Jean-David Fumet
Contact Person Email
jdfumet@cgfl.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Oncologie médicale
Contact Person Name
Yolanda Fernandez
Contact Person Email
y.fernandez@nancy.unicancer.fr
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Oncologie médicale
Contact Person Name
Antoine Angelergues
Contact Person Email
aangelergues@hopital-dcss.org
Site Name
Institut Bergonie
Department Name
Oncologie médicale
Contact Person Name
Coriolan Lebreton
Site Name
Centre Francois Baclesse
Department Name
Oncologie médicale
Contact Person Name
Florence Joly Lobbedez
Contact Person Email
f.joly@baclesse.unicancer.fr

Germany

Earliest CTIS Part Ii Submission Date
23-04-2024
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
702
Number Of Sites
5
Number Of Participants
31

Sites

Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
NCT/UCC
Contact Person Name
Pauline Wimberger
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Gynaecology
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynäkologie
Contact Person Name
Barbara Schmalfeldt
Contact Person Email
b.schmalfeldt@uke.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Fabienne Schochter
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Gynäkologie und Gynäkologische Onkologie
Contact Person Name
Florian Heitz
Contact Person Email
f.heitz@kem-med.com

Greece

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
769
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
Department Name
1st Oncology Clinic
Contact Person Name
Christos Papadimitriou
Contact Person Email
chr_papadim@yahoo.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Contact Person Name
Elena Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.
Department Name
3rd Department of Gynecologic Oncology
Contact Person Name
Ioannis Syrios
Contact Person Email
ISyrios@hygeia.gr
Site Name
Areteio Hospital
Department Name
B' Surgery Clinic, Oncology Unit
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk

Poland

Earliest CTIS Part Ii Submission Date
14-05-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
682
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Siedleckie Centrum Onkologii
Contact Person Name
Lubomir Bodnar
Contact Person Email
Lbodnar@szpital.siedlce.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej
Contact Person Name
Dagmara Klasa-Mazurkiewicz
Contact Person Email
dklasa@gumed.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Uniwersyteckie Centrum Onkologii
Contact Person Name
Paweł Knapp
Contact Person Email
pawel.knapp@umb.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Ginekologii Onkologicznej
Contact Person Name
Radosław Mądry
Contact Person Email
radoslaw.madry@usk.poznan.pl

Finland

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
534
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Pohjois-Savon hyvinvointialue
Department Name
Kuopio University Hospital, Obstetrics and Gynecology
Contact Person Name
Maarit Anttila

Czechia

Earliest CTIS Part Ii Submission Date
06-05-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
690
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Porodnická a gynekologická klinika
Contact Person Name
Ivan Práznovec
Contact Person Email
ivan.praznovec@fnhk.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Gynekologicko-porodnická klinika, Onkogynekologické centrum
Contact Person Name
David Cibula
Contact Person Email
dc@davidcibula.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Contact Person Name
Markéta Bednaříková
Contact Person Email
bednarikova.marketa@fnbrno.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
Michal Zikán
Contact Person Email
michal.zikan@bulovka.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika 2. LF UK a FN Motol
Contact Person Name
Anna Nohejlová Medková
Contact Person Email
anna.nohejlova@fnmotol.cz

Portugal

Earliest CTIS Part Ii Submission Date
03-05-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
693
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Hospital Professor Doutor Fernando Fonseca E.P.E.
Department Name
Oncology
Contact Person Name
Sofia Braga
Contact Person Email
sofia.braga@hff.min-saude.pt
Site Name
Hospital Da Luz S.A.
Department Name
Oncology
Contact Person Name
Mónica Nave
Contact Person Email
mnave@hospitaldaluz.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncology
Contact Person Name
Joana Bordalo e Sá
Contact Person Email
joana.sa@ipoporto.min-saude.pt
Site Name
Champalimaud Clinical Centre
Department Name
Oncology
Contact Person Name
Filipa Silva

Italy

Earliest CTIS Part Ii Submission Date
08-05-2024
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
687
Number Of Sites
11
Number Of Participants
79

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia Medica
Contact Person Name
Sabrina Chiara Cecere
Contact Person Email
sabrinacecere@hotmail.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Ginecologia
Contact Person Name
Annamaria Ferrero
Contact Person Email
a.ferrero0505@gmail.com
Site Name
Humanitas Research Hospital
Department Name
Ginecologia Oncologica
Contact Person Name
Domenica Lorusso
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Ginecologia
Contact Person Name
Vanda Salutari
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Ginecologia
Contact Person Name
Andrea Alberto Lissoni
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
Ginecologia
Contact Person Name
Giuseppa Scandurra
Contact Person Email
giusy.scandurra@gmail.com
Site Name
Careggi University Hospital
Department Name
Ginecologia Oncologica
Contact Person Name
Maria Cristina Petrella
Site Name
European Institute Of Oncology S.r.l.
Department Name
Ginecologia Oncologica
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncologia Medica e Prevenzione Oncologica
Contact Person Name
Michele Bartoletti
Contact Person Email
michele.bartoletti@cro.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Ginecologia Oncologica
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Ginecologia
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it

Spain

Earliest CTIS Part Ii Submission Date
10-05-2024
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
685
Number Of Sites
11
Number Of Participants
78

Sites

Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Contact Person Name
Andres Redondo Sanchez
Contact Person Email
aredondo12@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
Antonio Casado Herráez
Contact Person Email
antoniocasado6@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
David Garcia Illescas
Contact Person Email
dgillescas@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Contact Person Name
Luis Manuel Manso Sanchez
Contact Person Email
luismansosanchez@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Medical Oncology
Contact Person Name
Helena Selica de La Cueva Sapiña
Contact Person Email
delacueva_hel@gva.es
Site Name
Hospital Universitario De Jaen
Department Name
Medical Oncology
Contact Person Name
Fernando Galvez Montosa
Contact Person Email
fagalmon@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Iris Teruel Garcia
Contact Person Email
iteruel@iconcologia.net
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Medical Oncology
Contact Person Name
Antonio Gonzalez Martin
Contact Person Email
agonzalezma@unav.es
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Lydia Gaba Garcia
Contact Person Email
lgaba@clinic.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Contact Person Name
Jose Alejandro Perez-Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Medical Oncology
Contact Person Name
Antonio Gonzalez Martin
Contact Person Email
agonzalezma@unav.es

Sponsor

Primary sponsor

Full Name
Daiichi Sankyo Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsor duties listed (see dossier); (codes in record) 1,12,2,5
Name
PPD Development LP / Pharmaceutical Product Development LLC
Responsibilities
sponsor duties listed (see dossier); code 4
Name
Fortrea Inc.
Responsibilities
sponsor duties listed (see dossier); code 6
Name
Medidata Solutions Inc.
Responsibilities
sponsor duties listed (see dossier); code 7
Name
Suvoda LLC
Responsibilities
sponsor duties listed (see dossier); code 3

Third parties

  • {"country":"Japan","full_name":"Daiichi Sankyo Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central laboratory routing samples for specialty laboratories","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Neogenomics Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Independent central imaging reviewer","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Arcagy Gineco","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePROS/central ECG/ILD adjudication committee","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Raludotatug Deruxtecan
Active Substance
RALUDOTATUG DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
1
Maximum Dose
6.4 mg/kg
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
2
Maximum Dose
80 mg/m2
Investigational Product Name
TOPOTECAN
Active Substance
TOPOTECAN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
2
Maximum Dose
4 mg/m2
Investigational Product Name
DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL
Active Substance
DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
2
Maximum Dose
40 mg/m2

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