Clinical trial • Phase III • Oncology

DB-1303 for Breast cancer (HER2-low, hormone receptor positive, metastatic)

Phase III trial of DB-1303 for Breast cancer (HER2-low, hormone receptor positive, metastatic).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer (HER2-low, hormone receptor positive, metastatic)
Trial Stage
Phase III
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
03-11-2023
First CTIS Authorization Date
11-03-2024

Trial design

Randomised, open-label, investigator’s choice single-agent chemotherapy: capecitabine (oral film-coated tablet; dose unit mg/m2; max daily dose amount recorded 1250 mg/m2), paclitaxel (concentrate for solution for infusion; dose unit mg/m2; max daily dose amount recorded 80 mg/m2), and paclitaxel albumin-bound / nab‑paclitaxel (dispersion for infusion; dose unit mg/m2; max daily dose amount recorded 100 mg/m2).-controlled Phase III trial in France, Belgium, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator’s choice single-agent chemotherapy: capecitabine (oral film-coated tablet; dose unit mg/m2; max daily dose amount recorded 1250 mg/m2), paclitaxel (concentrate for solution for infusion; dose unit mg/m2; max daily dose amount recorded 80 mg/m2), and paclitaxel albumin-bound / nab‑paclitaxel (dispersion for infusion; dose unit mg/m2; max daily dose amount recorded 100 mg/m2).
Target Sample Size
442

Eligibility

Recruits 442 Vulnerable populations were not selected for inclusion (isVulnerablePopulationSelected false). Participants must be adults (≥18 years or acceptable local age). Individuals dependent on the Sponsor/clinical site/Investigator or committed to an institution are specifically excluded. Informed consent is documented via main ICF and related participant information sheets (country-specific ICFs provided)..

Pregnancy Exclusion
Pregnant or breastfeeding female subjects, or subjects who are planning to become pregnant.
Vulnerable Population
Vulnerable populations were not selected for inclusion (isVulnerablePopulationSelected false). Participants must be adults (≥18 years or acceptable local age). Individuals dependent on the Sponsor/clinical site/Investigator or committed to an institution are specifically excluded. Informed consent is documented via main ICF and related participant information sheets (country-specific ICFs provided).

Inclusion criteria

  • {"criterion_text":"- Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent)"}
  • {"criterion_text":"- Adequate organ and bone marrow function within 14 days before randomization."}
  • {"criterion_text":"- Has adequate treatment washout period before randomization, as defined in the protocol."}
  • {"criterion_text":"- Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner."}
  • {"criterion_text":"- Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 7 months after the last dose of study treatment."}
  • {"criterion_text":"- Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening and throughout the duration of the study treatment and the washout period (4 months after the last dose of DB-1303, 6 months after the last dose of paclitaxel or nab-paclitaxel, and 3 months after the last dose of capecitabine)."}
  • {"criterion_text":"- Pathologically documented breast cancer that: 1) Is advanced or metastatic 2) Has HER2low expression (IHC 1+ or IHC 2+/ISH-) 3) Was never previously reported as HER2-positive (IHC 3+ or ISH+) as per ASCO/CAP guidelines. 4) Is documented as HR+ (either ER and/or PgR positive [ER or PgR ≥1%]) per ASCO/CAP guidelines. "}
  • {"criterion_text":"- Must have an adequate tumor tissue sample available for assessment of HER2 by central laboratory, in formalin fixation and paraffin embedding (FFPE) blocks based on a mandatory FFPE tumor sample preferably obtained at the time of metastatic disease or later."}
  • {"criterion_text":"- ECOG performance status of 0 or 1"}
  • {"criterion_text":"- Must have had either: 1) Disease progression on endocrine therapy + CDK4/6 inhibitor within 6 months of starting first line treatment for metastatic disease and considered appropriate for chemotherapy as the next treatment by the investigator, OR 2) Disease progression on at least 2 previous lines of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease."}
  • {"criterion_text":"- No prior chemotherapy for advanced or metastatic breast cancer. Subjects who have received chemotherapy in the neo-adjuvant or adjuvant setting are eligible, as long as they have had a disease-free interval (defined as completion of systemic chemotherapy to diagnosis of advanced or metastatic disease) of >12 months."}
  • {"criterion_text":"- Life expectancy ≥12 weeks at screening."}
  • {"criterion_text":"- Subjects must have at least one measurable lesion as defined per RECIST v1.1, (For bone-only disease, subjects with lytic or mixed lytic bone lesions that can be measured by CT or MRI are eligible; subjects with sclerotic/osteoblastic bone lesions are not eligible)."}
  • {"criterion_text":"- Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before randomization."}

Exclusion criteria

  • {"criterion_text":"- Ineligible for all options in the investigator’s choice chemotherapy arm. Subjects with contraindications to capecitabine, paclitaxel, and nab-paclitaxel treatment, per local prescribing information, cannot be enrolled to the study."}
  • {"criterion_text":"- Prior randomization or treatment in a previous DB-1303 study regardless of treatment assignment"}
  • {"criterion_text":"- Participation in another clinical study with a study treatment administered recently (i.e. the washout period is less than five half-lives prior to the first dose of study treatment or 30 days prior to the first dose of study treatment if the half-life is unknown) or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow up period of an interventional study. Of note, tissue screening for this study while a subject is on follow-up in another clinical study is acceptable."}
  • {"criterion_text":"- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent."}
  • {"criterion_text":"- Has substance abuse or any other medical conditions such as psychological conditions, that may, in the opinion of the Investigator, interfere with the subject’s participation in the clinical study or evaluation of the clinical study results."}
  • {"criterion_text":"- Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring repeated drainage, peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to the randomization."}
  • {"criterion_text":"- Uncontrolled or significant cardiovascular disease"}
  • {"criterion_text":"- Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis /, pulmonary fibrosis, and radiation pneumonitis, which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected have these diseases by imaging at screening."}
  • {"criterion_text":"- Subjects with prior use of immunosuppressive medication within 14 days prior to first study dose, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses less than 10 mg/day of prednisone or equivalent."}
  • {"criterion_text":"- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months prior to study randomization, severe asthma, severe chronic obstructive pulmonary disorder [COPD], restrictive lung disease, significant pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete)."}
  • {"criterion_text":"- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals within 14 days prior to the first dose of study treatment."}
  • {"criterion_text":"- Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Subjects should be tested for HIV prior to randomization if required by local regulations or by the institutional review board (IRB)/independent ethics committee (IEC)"}
  • {"criterion_text":"- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants within 7 days prior to first study dose may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study randomization."}
  • {"criterion_text":"- Individuals who are dependent on the Sponsor, clinical site, or Investigator (e.g., is an employee of the Sponsor or the clinical trial site, a dependent of the Investigator, or any site staff member otherwise supervised by the Investigator)."}
  • {"criterion_text":"- Individuals who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, in accordance with local regulations."}
  • {"criterion_text":"- Receipt of live, attenuated vaccine (mRNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study treatment. Note: Subjects, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of study treatment."}
  • {"criterion_text":"- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline or Grade ≤ 2 anemia."}
  • {"criterion_text":"- Pregnant or breastfeeding female subjects, or subjects who are planning to become pregnant."}
  • {"criterion_text":"- Subjects with a known hypersensitivity to either the drug substances, inactive ingredients in the drug product or other monoclonal antibodies."}
  • {"criterion_text":"- History of another primary malignancy within 3 years, except adequately resected non melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral breast cancer."}
  • {"criterion_text":"- Previous treatment with anti-HER2 therapy"}
  • {"criterion_text":"- Prior treatment with antibody-drug conjugate that comprised an exatecan derivative that is a topoisomerase I inhibitor"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS by BICR according to response evaluation criteria in solid tumors (RECIST) 1.1 in the HR+, HER2-low population","definition_or_measurement_approach":"Progression-free survival assessed by blinded independent central review (BICR) using RECIST v1.1 in HR+, HER2-low (IHC 2+/ISH- and IHC 1+) population."}

Secondary endpoints

  • {"endpoint_text":"- OS in the HR+, HER2-low population","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomization to death in HR+, HER2-low population."}
  • {"endpoint_text":"- ORR and DoR by BICR and Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population","definition_or_measurement_approach":"Objective response rate (ORR) and duration of response (DoR) assessed by blinded independent central review (BICR) and investigator assessment per RECIST 1.1."}
  • {"endpoint_text":"- PFS by Investigator assessment according to RECIST 1.1 in the HR+, HER2-low population","definition_or_measurement_approach":"Progression-free survival assessed by investigator using RECIST 1.1."}
  • {"endpoint_text":"- TEAEs and SAEs per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, physical examinations, changes from baseline in laboratory findings, electrocardiograms (ECGs), ECHO/MUGA and vital signs.","definition_or_measurement_approach":"Safety assessed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded per NCI CTCAE v5.0, plus clinical and laboratory monitoring, ECGs, ECHO/MUGA and vital signs."}
  • {"endpoint_text":"- The patient reported outcomes (PROs) include: change from baseline in EORTC QLQC30 and EORTC QLQ-BR45 Scale scores, time to deterioration in EORTC QLQ-C30 scores","definition_or_measurement_approach":"PROs measured by EORTC QLQ-C30 and QLQ-BR45 questionnaires; endpoints include change from baseline and time to deterioration in QLQ-C30 scores."}
  • {"endpoint_text":"- EQ-5D-5L health state utility index","definition_or_measurement_approach":"Health utility measured using the EQ-5D-5L instrument (health state utility index)."}

Recruitment

Planned Sample Size
442
Recruitment Window Months
42
Consent Approach
Informed consent obtained from participants (adults ≥18 years or locally acceptable adult age) via main ICF and associated subject information sheets. Country-specific ICFs and information sheets available (versions listed for English, French, German, Italian, Polish, Hungarian, Spanish, Dutch). Separate ICFs for tissue screening and pregnant partner follow-up are provided where applicable.

Methods

  • Physician referral letters (Dr-to-Participant / Physician Referral Letter) — channel: referral via treating physicians; country-specific versions available (e.g., EN, FR, DE, IT, PL, HU, BE, ES).
  • Participant-facing materials (flyers, posters, brochures, participant brochures) — channel: site/community distribution and clinic display; country-specific versions available (EN, FR, DE, IT, PL, HU, BE, ES).
  • Patient-facing information and consent materials (ICF, patient information sheets, study guides, ID cards) provided at sites in multiple languages.

Geography

Total Number Of Sites
78
Total Number Of Participants
77

France

Earliest CTIS Part Ii Submission Date
17-01-2024
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
642
Number Of Sites
17
Number Of Participants
25

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Contact Person Name
Jean-Sébastien FRENEL
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Oncologie
Contact Person Name
Florence DALENC
Site Name
Oncoradio Centre Oncogard
Contact Person Name
Frédéric FITENI
Contact Person Email
frederic.fiteni@chu-nimes.fr
Site Name
Besancon University Hospital Center
Department Name
Oncologie médicale
Contact Person Name
Laura MANSI
Contact Person Email
lmansi@chu-besancon.fr
Site Name
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Department Name
Oncologie
Contact Person Name
Claire JAMET
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Contact Person Name
Julien GRENIER
Contact Person Email
j.grenier@isc84.org
Site Name
Polyclinique De Limoges
Department Name
Oncologie médicale
Contact Person Name
Dominique GENET
Contact Person Email
dg@imagemed-87.com
Site Name
Hospices Civils De Lyon
Department Name
Oncologie Médicale
Contact Person Name
Julien PERON
Contact Person Email
julien.peron@chu-lyon.fr
Site Name
Centre Henri Becquerel
Department Name
Centre de Lutte contre le Cancer
Contact Person Name
Florian CLATOT
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Oncologie
Contact Person Name
Thomas GRELLETY
Contact Person Email
tgrellety@ch-cotebasque.fr
Site Name
Polyclinique Bordeaux Nord Aquitaine
Department Name
Radiothérapie
Contact Person Name
Nadine DOHOLLOU
Contact Person Email
n.dohollou@bordeauxnord.com
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Oncologie
Contact Person Name
Elias ASSAF
Contact Person Email
elias.assaf@hmn.aphp.fr
Site Name
Centre Oscar Lambret
Department Name
Oncologie
Contact Person Name
Emilie KACZMAREK
Contact Person Email
e.kaczmarek@o-lambret.fr
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncologie médicale
Contact Person Name
Anne PATSOURIS
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Oncologie multidisciplinaire et innovations thérapeutiques
Contact Person Name
Marjorie BACIUCHKA
Contact Person Email
marjorie.baciuchka@ap-hm.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Oncologie
Contact Person Name
Cristina VILLANUEVA
Contact Person Email
villanueva@ccgm.fr
Site Name
Assistance Publique Hopitaux De Paris (Porte 23)
Department Name
Sénopôle
Contact Person Name
Delphine COCHEREAU
Contact Person Email
delphine.cochereau@aphp.fr

Belgium

Earliest CTIS Part Ii Submission Date
13-02-2024
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
743
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
UZ Brussel
Department Name
Medical Oncology
Contact Person Name
Christel Fontaine
Contact Person Email
christel.fontaine@uzbrussel.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Oncology
Contact Person Name
Barbara Stragier
Contact Person Email
Barbara.stragier@azdelta.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Eline Naert
Contact Person Email
eline.naert@uzgent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Francois Duhoux
Contact Person Email
francois.duhoux@uclouvain.be
Site Name
UZ Leuven
Department Name
General Medical Oncology
Contact Person Name
Hans Wildiers
Contact Person Email
hans.wildiers@uzleuven.be
Site Name
CHU De Liege
Department Name
Oncology
Contact Person Name
Andrée Rorive
Contact Person Email
andree.rorive@chuliege.be

Germany

Earliest CTIS Part Ii Submission Date
17-01-2024
Latest Decision Or Authorization Date
24-09-2025
Processing Time Days
616
Number Of Sites
8
Number Of Participants
7

Sites

Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Hematology and Oncology
Contact Person Name
Christian Scholz
Contact Person Email
Christian.Scholz@vivantes.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Wolfram Malter
Contact Person Email
wolfram.malter@uk-koeln.de
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Gynäkologie
Contact Person Name
Michael Untch
Site Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Department Name
Clinic for Gynecology and Obstetrics
Contact Person Name
Michael Eichbaum
Site Name
Marien Hospital Witten
Department Name
Brustzentrum Witten
Contact Person Name
Monika Gräser
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik
Contact Person Name
Peter Fasching
Site Name
Marienhospital Bottrop gGmbH
Department Name
Gynäkologie und Geburtshilfe
Contact Person Name
Hans-Christian Kolberg
Site Name
Technische Universitat Dresden
Department Name
Gynäkologisches Krebszentrum und Regionales Brustzentrum
Contact Person Name
Theresa Link

Hungary

Earliest CTIS Part Ii Submission Date
12-01-2024
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
836
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Onkoradiológiai Osztály
Contact Person Name
András Szigeti
Contact Person Email
drszigetia.petz@gmail.com
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
Onkológiai osztály
Contact Person Name
Andrea Uhlyarik
Contact Person Email
andrea@uhlyarik.net
Site Name
Szent Lazar Megyei Korhaz
Department Name
Onkológia és Sugárterápiás Osztály
Contact Person Name
László Landherr
Contact Person Email
landherr@szlmk.hu
Site Name
Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika
Department Name
Belgyógyászati és Onkológiai Klinika, Onkológiai Profil
Contact Person Name
Gyöngyvér Szentmártoni
Contact Person Email
gyszentmartoni@gmail.com
Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Onkológiai Osztály
Contact Person Name
Károly Máhr
Contact Person Email
mahrkaroly1967@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso.study@kmk.hu
Site Name
Mruk-Med I Sp. z o.o.
Department Name
Mruk-Med I Sp. z o. o.
Contact Person Name
Andrzej Mruk
Contact Person Email
kmruk1@vp.pl

Italy

Earliest CTIS Part Ii Submission Date
17-11-2023
Latest Decision Or Authorization Date
23-09-2025
Processing Time Days
676
Number Of Sites
14
Number Of Participants
14

Sites

Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Oncologia
Contact Person Name
Angioletta Lasagna
Contact Person Email
a.lasagna@smatteo.pv.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Divisione di Senologia Medica
Contact Person Name
Marco Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Divisione di Oncologia
Contact Person Name
Michelino De Laurentiis
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Azienda Ospedaliera Universitaria Mater Domini
Department Name
Oncologia Medica Translazionale
Contact Person Name
Pierfrancesco Tassone
Contact Person Email
tassone@unicz.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
Oncologia Medica
Contact Person Name
José Hector Soto Parra
Contact Person Email
hsotoparra.ctu@gmail.com
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Oncologia Medica
Contact Person Name
Rebecca Pedersini
Contact Person Email
rebecca.pedersini@gmail.com
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 1
Contact Person Name
Giulia Bianchi
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
Dipartimento di Oncologia
Contact Person Name
Fabio Conforti
Contact Person Email
fabio.conforti@gavazzeni.it
Site Name
Azienda Ospedaliera Universitaria Integrata Di Verona
Department Name
Unita di Oncologia
Contact Person Name
Elena Fiorio
Contact Person Email
elena.fiorio@aovr.veneto.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (duplicate entry in record)
Contact Person Name
Rebecca Pedersini
Contact Person Email
rebecca.pedersini@gmail.com
Site Name
Ospedale San Raffaele (additional site entry)
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
European Institute Of Oncology (additional site entry)
Contact Person Name
Marco Colleoni
Contact Person Email
marco.colleoni@ieo.it

Poland

Earliest CTIS Part Ii Submission Date
08-02-2024
Latest Decision Or Authorization Date
23-09-2025
Processing Time Days
593
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć
Contact Person Name
Anna Szafryna-Kliwicka
Contact Person Email
anna.szafryna-kliwicka@wco.pl
Site Name
Instytut Msf Sp. z o.o.
Department Name
Instytut Medyczny Santa Familia
Contact Person Name
Ewa Kalinka
Contact Person Email
imsf.clinicaltrials@gmail.com
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii, Centrum Wsparcia Badań Klinicznych
Contact Person Name
Renata Duchnowska
Contact Person Email
rdtt@wp.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Toruń
Contact Person Name
Justyna Wietrzyńska
Contact Person Email
ewa.rymko@medicover.com
Site Name
Futuremeds Sp. z o.o.
Department Name
Futuremeds Wrocław
Contact Person Name
Damian Ślepecki
Contact Person Email
damian.slepecki@futuremeds.com
Site Name
Mruk-Med I Sp. z o.o.
Department Name
Mruk-Med I Sp. z o. o.
Contact Person Name
Andrzej Mruk
Contact Person Email
kmruk1@vp.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Onkologii
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@uj.edu.pl

Spain

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
784
Number Of Sites
19
Number Of Participants
7

Sites

Site Name
Hospital Universitari General De Catalunya
Department Name
Oncology
Contact Person Name
Xavier Gonzalez
Contact Person Email
xgonzalez@oncorosell.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Maite Martinez
Contact Person Email
maitemartinez3@yahoo.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
Luis de la Cruz
Contact Person Email
ldelacruzmerino@gmail.com
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Contact Person Name
Alvaro Rodriguez
Contact Person Email
alvaro.rodriguez@iob-onco.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Yann Izarzugaza
Contact Person Email
yizarzugaza@fjd.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Contact Person Name
Blanca Cantos
Contact Person Email
blanca.cantos@salud.madrid.org
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncology
Principal Investigator Name
Maria Luisa Sanchez Lorenzo
Principal Investigator Email
lsanchez@unav.es
Contact Person Name
Xavier Gonzalez (Pamplona contact)
Contact Person Email
lsanchez@unav.es
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Principal Investigator Name
Maria Isabel Blancas López-Barajas
Principal Investigator Email
isabelblancas@hotmail.com
Contact Person Name
Luis de la Cruz (local contact)
Contact Person Email
ldelacruzmerino@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Tomas Pascual
Contact Person Email
topascual@clinic.cat
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Contact Person Name
Lucia Gonzalez
Contact Person Email
lucia.gonzalezc@quironsalud.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
María Galan Gramaje
Contact Person Email
galan38@hotmail.com
Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Sonia Servitja
Contact Person Email
sservitja@parcdesalutmar.cat
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Contact Person Name
Emilia Domínguez
Contact Person Email
emilia.dominguez@ibima.eu
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Fernando Moreno
Contact Person Email
fmorenoa@salud.madrid.org
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Oncology
Principal Investigator Name
Maria Luisa Sanchez Lorenzo
Principal Investigator Email
lsanchez@unav.es
Contact Person Name
Maria Luisa Sanchez Lorenzo
Contact Person Email
lsanchez@unav.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Francisco Javier Salvador
Contact Person Email
jsalvad2002@yahoo.es
Site Name
Hospital Vithas Parque San Antonio
Department Name
Oncology
Contact Person Name
Javier Pascual López
Contact Person Email
javier.pascual@ext.vithas.es
Site Name
Universidade De Santiago De Compostela
Department Name
Oncology
Contact Person Name
Rafael Lopez
Contact Person Email
rafael.lopez.lopez@sergas.es
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Contact Person Name
Maria Gion
Contact Person Email
mariagion@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
multiple sponsor duties (codes: 1, 12, 13, 2, 5, 6, 8) including clinical trial operations and data activities (per sponsorDuties codes)
Name
Parexel International Corp.
Responsibilities
IDMC duties (sponsorDuties code 15, value: IDMC)
Name
Medidata Solutions Inc.
Responsibilities
data/EDC related duties (sponsorDuties codes: 3,7)
Name
Bioclinica Shanghai Co. Ltd.
Responsibilities
central imaging & ILD adjudication (sponsorDuties codes: 13; 15)
Name
Labcorp Central Laboratory Services S.a.r.l.
Responsibilities
central laboratory services (sponsorDuties code: 4)

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 3, 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"sponsorDuties codes: 14, 15 (QP Release Site)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 13, 2, 5, 6, 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties codes: 15 (IDMC)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties codes: 15 (Diagnostic Partner)","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Bioclinica Shanghai Co. Ltd.","duties_or_roles":"sponsorDuties codes: 13; 15 (Central imaging & Interstitial lung disease Adjudication)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
DB-1303
Active Substance
DB-1303
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
1250 mg/m2 (max daily dose amount as recorded)
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Maximum Dose
80 mg/m2 (max daily dose amount as recorded)
Investigational Product Name
PACLITAXEL ALBUMIN-BOUND
Active Substance
PACLITAXEL ALBUMIN-BOUND
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Maximum Dose
100 mg/m2 (max daily dose amount as recorded)

Related trials

Other published trials that may interest you.