Clinical trial • Phase II • Oncology

PATRITUMAB DERUXTECAN for Locally advanced or metastatic solid tumors

Phase II trial of PATRITUMAB DERUXTECAN for Locally advanced or metastatic solid tumors. open-label. 367 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced or metastatic solid tumors
Trial Stage
Phase II
Drug Modality
ADC

Key dates

Initial CTIS Submission Date
23-01-2024
First CTIS Authorization Date
06-05-2024

Trial design

open-label Phase II trial in Belgium, France, Spain and others.

Open Label
Yes
Target Sample Size
367
Trial Duration For Participant
885

Eligibility

Recruits 367 Vulnerable population flag is selected. Only participants aged ≥18 years are eligible (note: follow local regulatory requirements if legal age of consent >18). Informed consent is required and must be signed and dated prior to any study-specific procedures. Separate consents are used for tumour tissue screening, the qualitative interview sub-study and for audio recording; there are country-specific ICFs and participant information documents. No assent procedures for minors are described (minors are excluded by age criterion)..

Pregnancy Exclusion
Is a female subject who is pregnant or breastfeeding or intends to become pregnant during the study
Vulnerable Population
Vulnerable population flag is selected. Only participants aged ≥18 years are eligible (note: follow local regulatory requirements if legal age of consent >18). Informed consent is required and must be signed and dated prior to any study-specific procedures. Separate consents are used for tumour tissue screening, the qualitative interview sub-study and for audio recording; there are country-specific ICFs and participant information documents. No assent procedures for minors are described (minors are excluded by age criterion).

Inclusion criteria

  • {"criterion_text":"- Sign and date the ICF, prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n- A male, subject capable of producing sperm is eligible to participate if he agrees to the following, during the intervention period, and for at least the time needed the trial intervention. The length of time required to continue contraception after last dose for the trial intervention is ≥4 months(see details on page 103)\n- Male subjects must not freeze or donate sperm starting at screening and throughout the study period and ≥4 months after the final study drug administration.\n- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.\n- Sub study: Participant is taking part in the Phase II open-label study.\n- Sub study: Participant provides consent to participate in the interview sub-study via the Study Informed Consent Form (ICF).\n- Sub study: Participant consents to be audio recorded.\n- Sub study: Participant resides in Belgium, Spain, Japan, Korea, Taiwan, continental US (Puerto Rico is excluded), UK, Australia, Canada, Czech Republic, Germany, Hungary, Italy, Norway, The Netherlands\n- Sub study: Participant can communicate and read fluently in country local language including Belgian-French, Spanish, Japanese, Korean, Taiwanese-Mandarin, Canadian-French, Czech, German, Hungarian, Italian, Norwegian, Dutch or English.\n- Sub study: Participant is physically able to participate in a one-on-one, approximately 45-minute interview (conducted in one sitting) using an internet-enabled computer or other device (such as a tablet) with screensharing / screen-viewing capabilities\n- Subject aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old\n- Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) (see details on page 99)\n- Has ≥1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 by investigator assessment. Prostate cancer subjects with bone only disease may be eligible.\n- Provides a pretreatment tumor tissue sample that meets 1 of the collection requirements (see details on page 103)\n- Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening\n- Has adequate bone marrow reserve and organ function based on local laboratory data within 7days prior to Cycle 1 Day (see table starting on page 103)\n- If the subject is a female of childbearing potential, she must have a negative serum pregnancy test at screening and must be willing to use highly effective birth control upon enrolment, during the Treatment Period, and for 7 months following the last dose of study drug (see table on page 103).\n- Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study Treatment Period and for ≥7 months after the final study drug administration."}

Exclusion criteria

  • {"criterion_text":"- Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations)\n- Had inadequate washout period prior to Cycle 1 Day 1 (see details on page 105)\n- Had prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate (ADC) that consists of a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved by the National Cancer Institute – Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) to Grade ≤1 or baseline (see details on page 105).\n- Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following: a. Adequately treated nonmelanoma skin cancer and adequately treated thin primary melanoma <1 mm. b. Adequately treated intraepithelial carcinoma of the cervix c. Any other curatively treated in situ disease. d. Early prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) not requiring treatment\n- Has uncontrolled or significant cardiovascular disorder prior to Cycle 1 Day 1 (see details on page 106)\n- Has active or uncontrolled hepatitis C virus infection infection (see details on page 106).\n- Has uncontrolled HIV1/2 infection (see details on page 107).\n- Has active or uncontrolled HBV infection (see details on page 107).\n- Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness/social situations, geographical factors, substance abuse, or other factors that, in the investigator’s opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol.\n- Has known hypersensitivity to either the drug substance or inactive ingredients in the drug product.\n- Has nasopharyngeal cancer\n- Is a female subject who is pregnant or breastfeeding or intends to become pregnant during the study\n- Has 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 subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results\n- Has previously received topoisomerase-1 inhibitors (e.g., irinotecan treatment in the advanced or metastatic disease)\n- Sub study: Participant is unable to adhere to the requirements of the interview sub-study\n- Has mucosal or uveal melanoma\n- Has a history of (non- infectious) ILD that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging during screening.\n- Has clinically severe respiratory compromise (based on the investigator’s assessment) resulting from intercurrent pulmonary illnesses (see details on page 104)\n- Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Subjects who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study\n- Has any history of or evidence of current leptomeningeal disease\n- Has clinically significant corneal disease\n- Has evidence of clinically active spinal cord compression or brain metastases, defined as being symptomatic or untreated, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and not requiring treatment with corticosteroids or anticonvulsants) may be included in the study but must have a stable neurologic status for ≥4 weeks prior to Cycle 1 Day 1. Subjects with asymptomatic brain metastases and treated with anticonvulsants as prophylaxis are able to enroll."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint of the study is ORR as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). for all cohorts except Prostate cancer cohort","definition_or_measurement_approach":"Objective Response Rate (ORR) assessed by investigator per RECIST v1.1"}
  • {"endpoint_text":"- For Prostate Cohort only:The PE is PSA50. Changes in PSA have been shown to correlate with OS, and this EP will allow for timely understanding of the antitumor activity in parallel with available safety endpoints. PSA50 response rate, defined as the proportion of patients with a ≥50% decrease in PSA level from baseline to the lowest postbaseline PSA result, confirmed by a consecutive PSA assessment at least 3 weeks later has been used in other clinical studies in prostate cancer","definition_or_measurement_approach":"PSA50 response rate defined as proportion of patients with ≥50% decrease in PSA from baseline to lowest postbaseline PSA, confirmed by a consecutive PSA assessment at least 3 weeks later"}

Secondary endpoints

  • {"endpoint_text":"- TEAEs and other safety parameters during the study","definition_or_measurement_approach":"Treatment-emergent adverse events (TEAEs) and other safety parameters collected throughout study per standard safety reporting"}
  • {"endpoint_text":"- Duration of response (DoR)","definition_or_measurement_approach":"Time from first documented response to disease progression or death"}
  • {"endpoint_text":"- Clinical benefit rate (CBR)","definition_or_measurement_approach":"Proportion of patients achieving predefined clinical benefit (as defined in protocol)"}
  • {"endpoint_text":"- Disease control rate (DCR)","definition_or_measurement_approach":"Proportion of patients achieving response or stable disease per protocol definitions"}
  • {"endpoint_text":"- Time to response (TTR)","definition_or_measurement_approach":"Time from treatment start to first documented response"}
  • {"endpoint_text":"- Progression-free survival (PFS) evaluated by the investigator per RECIST v1.1","definition_or_measurement_approach":"PFS determined by investigator assessment per RECIST v1.1"}
  • {"endpoint_text":"- Overall survival (OS), including Prostate cancer cohort","definition_or_measurement_approach":"Time from randomisation/enrolment to death from any cause"}
  • {"endpoint_text":"- PK endpoints, including Prostate cancer cohort","definition_or_measurement_approach":"Pharmacokinetic parameters as defined in protocol (eg, Cmax, AUC)"}
  • {"endpoint_text":"- Correlation between HER3 protein expression at baseline (as determined by HER3 IHC assay) and efficacy, , including Prostate cancer cohort","definition_or_measurement_approach":"Assessment of baseline HER3 protein expression by HER3 IHC assay and correlation analyses with efficacy endpoints"}
  • {"endpoint_text":"- For Prostate cohort only: rPFS (PCWG3)","definition_or_measurement_approach":"Radiographic PFS assessed per PCWG3 criteria"}
  • {"endpoint_text":"- For Prostate cohort only: PSA30 response rate","definition_or_measurement_approach":"Proportion of patients with ≥30% decrease in PSA from baseline"}
  • {"endpoint_text":"- For Prostate cohort only: Time to first subsequent anticancer therapy (TFST)","definition_or_measurement_approach":"Time from study treatment start to initiation of first subsequent anticancer therapy"}
  • {"endpoint_text":"- For Prostate cohort only: Time to first symptomatic skeletal-related event (SSRE)","definition_or_measurement_approach":"Time from study treatment start to first symptomatic skeletal-related event"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
367
Recruitment Window Months
29
Consent Approach
Written informed consent (ICF) must be signed and dated by the participant prior to any study-specific procedures. Separate consent documents are used for tumor tissue screening, biosample collections, pregnant partner procedures and for the qualitative interview sub-study (including audio recording). Country- and language-specific ICFs are provided (multiple language versions and country-specific ICFs available). Participants must be ≥18 years (or meet local legal age of consent).

Methods

  • Physician Referral Letter / Doctor-to-Patient Letter (country-specific materials exist: e.g., DE, FR, NL, EN) - materials for clinicians to refer eligible patients
  • Patient Brochure / Patient Study Guide (country-specific versions) - informational materials provided to potential participants
  • Sub-study Patient Information Leaflet and Interview materials (EN/FR/NL/IT/ES versions) for recruitment to the qualitative interview sub-study
  • Clincierge platform materials (Hungary): Clincierge welcome letter, Pay Portal guidance and participant-facing documents (used for participant communications and payments)

Geography

Total Number Of Sites
47
Total Number Of Participants
373

Belgium

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
689
Number Of Sites
5
Number Of Participants
32

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@ugent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Cédric Van Marcke de Lummen
Site Name
UZ Leuven
Department Name
Medical Oncology
Contact Person Name
Oliver Bechter
Contact Person Email
oliver.bechter@uzleuven.be
Site Name
UZ Brussel
Department Name
Medical Oncology
Contact Person Name
Amy de Haar-Holleman
Site Name
Antwerp University Hospital
Department Name
Medical Oncology
Contact Person Name
Hans Prenen
Contact Person Email
hans.prenen@uza.be

France

Earliest CTIS Part Ii Submission Date
25-04-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
683
Number Of Sites
9
Number Of Participants
167

Sites

Site Name
Centre Leon Berard
Department Name
Medical oncology
Contact Person Name
Jérome Fayette
Site Name
Centre Georges Francois Leclerc
Department Name
Medical oncology
Contact Person Name
François Ghiringhelli
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical oncology
Contact Person Name
Amaury Daste
Contact Person Email
amaury.daste@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Dermatology
Contact Person Name
Gaëlle Quereux
Contact Person Email
gaelle.quereux@chu-nantes.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Medical Oncology
Contact Person Name
Vincent Massard
Contact Person Email
v.massard@nancy.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Drug development department
Contact Person Name
Antoine Hollebecque
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Medical Oncology
Contact Person Name
Anthony Turpin
Contact Person Email
anthony.turpin@chu-lille.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Clinical research unit
Contact Person Name
Iphigénie Korakis
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Centre d'essais Précoces de Cancérologie de Marseille
Contact Person Name
Caroline GAUDY MARQUESTE
Contact Person Email
caroline.gaudy@ap-hm.fr

Spain

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
688
Number Of Sites
9
Number Of Participants
97

Sites

Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
Luis de la Cruz Merino
Contact Person Email
ldelacruzmerino@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Silvia García Adrián
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Francisco Carabantes Ocón
Contact Person Email
fcarabantes@hotmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Georgia Anguera Palacios
Contact Person Email
ganguera@santpau.cat
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Ivan Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Federico Longo Muñoz
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Guillermo de Velasco Oria de Rueda
Contact Person Email
gdevelasco.gdv@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Valentina Gambardella
Contact Person Email
valen.gambardella@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Julia Lostes Bardaji
Contact Person Email
jlostes@vhio.net

Germany

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
356
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Comprehensive Cancer Center
Contact Person Name
Sebastian Ochsenreither
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik fuer Haematologie
Contact Person Name
Stefan Kasper Virchow
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut fuer Klinisch- Onkologische Forschung (IKF)
Contact Person Name
Thorsten Goetze
Contact Person Email
goetze.thorsten@khnw.de

Hungary

Earliest CTIS Part Ii Submission Date
04-02-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
398
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Klinikai Onkologiai es Sugarterapias Centrum
Principal Investigator Name
Gergely Dombóvári
Principal Investigator Email
dombovaridr@freemail.hu
Contact Person Name
Gergely Dombóvári
Contact Person Email
dombovaridr@freemail.hu
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Onkologiai Osztaly
Principal Investigator Name
Yousuf Al-Farhat
Principal Investigator Email
yalfarhat@gmail.com
Contact Person Name
Yousuf Al-Farhat
Contact Person Email
yalfarhat@gmail.com
Site Name
Semmelweis University
Department Name
Szuleszeti es Nogyogyaszati Klinika Baross utcai r
Principal Investigator Name
Szabolcs Máté
Principal Investigator Email
dr.mate.szabolcs@gmail.com
Contact Person Name
Szabolcs Máté
Contact Person Email
dr.mate.szabolcs@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiologiai Kozpont
Principal Investigator Name
Zsolt Horváth
Principal Investigator Email
horvathzso.study@kmk.hu
Contact Person Name
Zsolt Horváth
Contact Person Email
horvathzso.study@kmk.hu
Site Name
University Of Debrecen
Department Name
Szuleszeti es Nogyogyaszati Klinika
Principal Investigator Name
Zoárd Krasznai
Principal Investigator Email
krasznai.zoard@med.unideb.hu
Contact Person Name
Zoárd Krasznai
Contact Person Email
krasznai.zoard@med.unideb.hu

Italy

Earliest CTIS Part Ii Submission Date
05-03-2025
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
378
Number Of Sites
8
Number Of Participants
23

Sites

Site Name
Cliniche Gavazzeni S.p.A.
Department Name
Oncology Department
Principal Investigator Name
Tommaso Martino De Pas
Principal Investigator Email
tommaso.depas@gavazzeni.it
Contact Person Name
Tommaso Martino De Pas
Contact Person Email
tommaso.depas@gavazzeni.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Medical Oncology Unit 1
Principal Investigator Name
Annamaria Pessino
Principal Investigator Email
Annamaria.pessino@hsanmartino.it
Contact Person Name
Annamaria Pessino
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
UOC Oncologia Medica
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
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncology Unit - AOU Integrata Verona - CRC
Principal Investigator Name
Michele Milella
Principal Investigator Email
michele.milella@univr.it
Contact Person Name
Michele Milella
Contact Person Email
michele.milella@univr.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology and Hematology
Principal Investigator Name
Claudio Zamagni
Principal Investigator Email
claudio.zamagni@aosp.bo.it
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Medical Oncology
Principal Investigator Name
Angelo Dipasquale
Principal Investigator Email
angelo.dipasquale@humanitas.it
Contact Person Name
Angelo Dipasquale
Contact Person Email
angelo.dipasquale@humanitas.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica I
Principal Investigator Name
Matteo Duca
Principal Investigator Email
matteo.duca@istitutotumori.mi.it
Contact Person Name
Matteo Duca
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli (additional listing)
Department Name
Oncology

Netherlands

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
339
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Oncology
Principal Investigator Name
Hans Gelderblom
Principal Investigator Email
b.a.hoogland@lumc.nl
Contact Person Name
Hans Gelderblom
Contact Person Email
b.a.hoogland@lumc.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Oncology
Principal Investigator Name
Ingrid Desar
Principal Investigator Email
ingrid.desar@radboudumc.nl
Contact Person Name
Ingrid Desar
Contact Person Email
ingrid.desar@radboudumc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Oncology
Principal Investigator Name
Loes Latten-Jansen
Principal Investigator Email
loes.jansen@mumc.nl
Contact Person Name
Loes Latten-Jansen
Contact Person Email
loes.jansen@mumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Oncology
Principal Investigator Name
Jourik Gietema
Principal Investigator Email
j.a.gietema@umcg.nl
Contact Person Name
Jourik Gietema
Contact Person Email
j.a.gietema@umcg.nl
Site Name
Amsterdam UMC Stichting
Department Name
Oncology
Principal Investigator Name
Mariette Labots
Principal Investigator Email
ctis@amsterdamumc.nl
Contact Person Name
Mariette Labots
Contact Person Email
ctis@amsterdamumc.nl

Norway

Earliest CTIS Part Ii Submission Date
02-04-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
341
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Akershus University Hospital
Department Name
Onkologisk Avdeling
Principal Investigator Name
Asa Dahle Smith
Principal Investigator Email
Asa.Dahle.Smith@ahus.no
Contact Person Name
Asa Dahle Smith
Contact Person Email
Asa.Dahle.Smith@ahus.no
Site Name
Helse Bergen HF
Department Name
Department of Cancer Treatment
Principal Investigator Name
Kjersti Tefre Davidsen
Principal Investigator Email
kjersti.tefre.davidsen@helse-bergen.no
Contact Person Name
Kjersti Tefre Davidsen
Site Name
Oslo University Hospital HF
Department Name
Department of oncology
Principal Investigator Name
Tormod Kyrre Guren
Principal Investigator Email
tormod.kyrre.guren@ous-hf.no
Contact Person Name
Tormod Kyrre Guren
Contact Person Email
tormod.kyrre.guren@ous-hf.no

Sponsor

Primary sponsor

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

Contract research organisations

Name
Iqvia Rds Ireland Limited
Responsibilities
sponsorDuties codes: 1,10,12,2,5,6
Name
Q Squared Solutions Limited
Responsibilities
collection and (preparation, if needed) of PK & ADA, tumor and blood biomarker samples
Name
Bioclinica Inc.
Responsibilities
imaging collection and storage
Name
Azenta US Inc.
Responsibilities
Biosample long term storage

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"imaging collection and storage","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"collection and (preparation, if needed) of PK & ADA, tumor and blood biomarker samples","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Iqvia Rds Ireland Limited","duties_or_roles":"sponsorDuties codes: 1,10,12,2,5,6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Biosample long term storage","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Patritumab deruxtecan
Active Substance
PATRITUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
5.60 mg/kg

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