Clinical trial • Phase III • Oncology

ZANIDATAMAB for Biliary tract cancer | Gallbladder cancer | Intrahepatic cholangiocarcinoma | Extrahepatic cholangiocarcinoma

Phase III trial of ZANIDATAMAB for Biliary tract cancer | Gallbladder cancer | Intrahepatic cholangiocarcinoma | Extrahepatic cholangiocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Biliary tract cancer | Gallbladder cancer | Intrahepatic cholangiocarcinoma | Extrahepatic cholangiocarcinoma
Trial Stage
Phase III
Drug Modality
Other antibody|Small molecule|Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
18-04-2024
First CTIS Authorization Date
12-08-2024

Trial design

Randomised, open-label, control arm: cisplatin plus gemcitabine (cisgem) for up to 8 cycles, with or without a pd-1/l1 inhibitor; experimental arm: zanidatamab plus cisgem (for up to 8 cycles) with or without a pd-1/l1 inhibitor. (pd-1/l1 inhibitor options noted in protocol: durvalumab or pembrolizumab where locally approved.) Phase III trial in Romania, Czechia, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Control arm: Cisplatin plus gemcitabine (CisGem) for up to 8 cycles, with or without a PD-1/L1 inhibitor; Experimental arm: zanidatamab plus CisGem (for up to 8 cycles) with or without a PD-1/L1 inhibitor. (PD-1/L1 inhibitor options noted in protocol: durvalumab or pembrolizumab where locally approved.)
Biomarker Stratified
True, biomarker: HER2 status with strata IHC 3+ and IHC 2+/ISH+
Target Sample Size
154

Eligibility

Recruits 154 Vulnerable population selection is indicated. All participants must be adults (≥18 years). The protocol requires written informed consent from participants; a separate written informed consent is required for pre-screening for HER2 status (collection, storage and analysis of tumour tissue). Additional ICFs for pregnancy/partner and pre-screening are provided. Consent documents are provided in multiple country/language-specific versions (see country ICF documents). No assent procedures for minors are required because minors are excluded..

Pregnancy Exclusion
Females who are breastfeeding or pregnant, and females and males planning a pregnancy.
Vulnerable Population
Vulnerable population selection is indicated. All participants must be adults (≥18 years). The protocol requires written informed consent from participants; a separate written informed consent is required for pre-screening for HER2 status (collection, storage and analysis of tumour tissue). Additional ICFs for pregnancy/partner and pre-screening are provided. Consent documents are provided in multiple country/language-specific versions (see country ICF documents). No assent procedures for minors are required because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- 1. Histologically- or cytologically-confirmed BTC, including GBC, ICC, or ECC.\n- 2. Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.\n- 3 . Received no more than 2 cycles of systemic therapy which is limited to CisGem with or without a PD-1/L1 inhibitor (physician’s choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease. Participants who have received prior adjuvant or neoadjuvant treatment (including investigational products) for earlier stage disease are permitted as long as therapy was completed more than 6 months prior to expected date of C1D1.\n- 4. HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and ISH assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy (See Section 7.1). Note that fine needle aspirates (FNAs; which obtain only cytology samples), cytology samples, brushings, and biopsies from sites of bone metastases are not acceptable. Biopsies obtained with a needle that provides intact tissue sample may be acceptable. Testing may occur with tissue obtained at any time after diagnosis of BTC and before randomization.\n- 5. Assessable (measurable or non-measurable) disease as defined by RECIST 1.1, per investigator assessment.\n- 6. Male or female ≥ 18 years of age (or the legal age of adulthood per country-specific regulations).\n- 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n- 8. Adequate hematologic function as follows: a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L b. Platelet count ≥ 100 × 109/L, not requiring transfusion support c. Hemoglobin (Hgb) ≥ 9 g/dL (participants with chronic anemia that is supported by intermittent red blood cell transfusions are eligible)\n- 9. Adequate hepatic function, as defined by both: a. Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN), and alanine aminotransferase (ALT) ≤ 3 × ULN. For participants with liver involvement, AST and ALT ≤ 5 × ULN is acceptable. b. Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN for participants with Gilbert’s disease\n- 10. Adequate renal function, as defined by estimated glomerular filtration rate (GFR) > 50 mL/min per local institutional standard method.\n- 11. Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA).\n- 12. Females of childbearing potential must have a negative serum/plasma or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 3 days (72 hours) prior to randomization. Females with false positive results can be enrolled if subsequent serum/plasma testing is negative.\n- 13. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control with a failure rate of less than 1% per year (HMA-(HMA-CTCG, 2024)) during the study and for 14 months after the last dose of cisplatin, 6 months after the last dose of gemcitabine, 4 months after the last dose of zanidatamab, 4 months after the last dose of pembrolizumab, and 3 months after the last dose of durvalumab.\n- 14. Females must agree to not donate oocytes starting at screening and throughout the study period, and for at least 14 months after the last dose of cisplatin, 6 months after the last dose of gemcitabine, 4 months after the last dose of zanidatamab, 4 months after the last dose of pembrolizumab, and 3 months after the last dose of durvalumab.\n- 15. Males must agree to use condoms and not to donate sperm starting at screening and throughout the study period, and for at least 11 months after the last dose of cisplatin, 4 months after the last dose of zanidatamab, and 6 months after the last dose of gemcitabine.\n- 16. Participant has life expectancy of greater than 3 months, in the opinion of the investigator.\n- 17. The participant must provide written informed consent. Participants who elect to be pre-screened for HER2 status must provide a separate written informed consent for collection, storage, and analysis of the tumor tissue."}

Exclusion criteria

  • {"criterion_text":"- 1. Prior treatment with a HER2-targeted agent, with the exception of participants who completed HER2targeted treatment for breast cancer > 5 years prior to their diagnosis of BTC.\n- 2. Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab as part of the up to 2 cycles of systemic therapy allowed prior to randomization per Inclusion Criterion 3. Exclusionary checkpoint inhibitors include but are not limited to other anti-PD-1, anti-PD-L1, anticytotoxic T lymphocyte-associated antigen (CTLA)-4 antibodies.\n- 3. The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.\n- 4. Received radiotherapy within 2 weeks of randomization.\n- 5. Had major surgery within 4 weeks of randomization.\n- 6. Total lifetime load of anthracycline exceeding 360 mg/m2 doxorubicin or equivalent.\n- 7. Use of systemic corticosteroids administered at doses equivalent to > 10 mg per day of prednisone within 2 weeks of randomization. Topical, ocular, intra-articular, intranasal, and/or inhalation corticosteroids are permitted.\n- 8. Brain metastases: Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of randomization. Stable, treated brain metastases are allowed (defined as participants who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening).\n- 9. Known history of or ongoing leptomeningeal disease (LMD). Participants will be eligible if LMD has been reported radiographically but is not suspected clinically by the investigator, and the participant does not have neurological symptoms of LMD.\n- 10. Poorly controlled seizures in the judgment of the investigator.\n- 11. Grade 2 or greater peripheral neuropathy that is related to prior cancer therapy.\n- 12. Concurrent uncontrolled or active hepatobiliary disorders or untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, unresolved biliary obstruction, infected biloma, or abscess. Any complications must be resolved at least 2 weeks prior to randomization.\n- 13. Prior or concurrent invasive malignancy whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n- 14. Severe chronic or active infections requiring systemic parenteral antibacterial, antifungal or antiviral therapy; or any other potentially life-threatening viral or bacterial infection (participants on oral antibiotics must complete the planned course of treatment prior to randomization).\n- 15. Active hepatitis, including the following: a. Acute or chronic hepatitis B (Exception: Participants who are hepatitis B surface antigen [HBsAg] positive are eligible if they have hepatitis B virus (HBV) DNA less than 500 IU/mL or 2,500 copies/mL). Note: Participants with detectable HBsAg or detectable HBV DNA should be managed per institutional or local standards. Participants beginning antiviral agents at screening should be treated for > 2 weeks prior to randomization. b. Infection with hepatitis C (Exceptions: [i] Participants who have no history of curative viral treatment and are documented to be viral load negative are eligible; [ii] Participants who have completed curative viral therapy ≥ 12 weeks or on concurrent hepatitis C virus treatment prior to expected date of C1D1, and viral load is negative are eligible.)\n- 16. Infection with human immunodeficiency virus (HIV)-1 or HIV-2. (Exception: Participants with wellcontrolled HIV [ie, CD4 > 350/mm3 and undetectable viral load] are eligible.)\n- 17. Active tuberculosis (TB).\n- 18. History of allogeneic organ transplantation.\n- 19. Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) with the exception of: a. Vitiligo or alopecia b. Endocrine disorders stable on replacement therapy (thyroxine, insuline, etc) c. Chronic skin conditions that do not require systemic therapy d. Celiac disease controlled by diet alone e. Primary sclerosing cholangitis Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment of the autoimmune disease and is allowed.\n- 20. History of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of any of the agents in the trial (cisplatin, gemcitabine, the selected PD1/L1 inhibitor, or zanidatamab).\n- 21. Known hypersensitivity to any components of the combination therapy.\n- 22. Ongoing, clinically significant toxicity (Grade 2 or higher) associated with prior cancer therapies, with the exception of alopecia.\n- 23. Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF). Participants with known myocardial infarction or unstable angina within 6 months (180 days) prior to randomization are also excluded. Previous anticancer therapy-related CHF must have been ≤ Grade 1 at the time of occurrence and must have completely resolved.\n- 24. History of interstitial lung disease or non-infectious pneumonitis.\n- 25. History of active primary immunodeficiency.\n- 26. Participation in another clinical trial with an investigational medicinal product within the last 3 months (90 days).\n- 27. Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease.\n- 28. Females who are breastfeeding or pregnant, and females and males planning a pregnancy.\n- 29. Any other medical, social, or psychosocial factors (eg, hearing impairment) that, in the opinion of the investigator, could impact safety or compliance with study procedures.\n- 30. Use of prophylactic phenytoin."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) in the immunohistochemistry (IHC) 3+ subgroup","definition_or_measurement_approach":"PFS measured per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, v1.1) in the IHC 3+ subgroup."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS) in the IHC 3+ subgroup","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PFS per RECIST 1.1 in the overall population","definition_or_measurement_approach":"Per RECIST 1.1"}
  • {"endpoint_text":"- OS in the overall population","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Confirmed objective response rate (cORR) per RECIST 1.1","definition_or_measurement_approach":"Per RECIST 1.1"}
  • {"endpoint_text":"- Duration of response (DOR) per RECIST 1.1","definition_or_measurement_approach":"Per RECIST 1.1"}
  • {"endpoint_text":"- Frequency, severity, seriousness, and relatedness of treatment-emergent adverse events (AEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Serum concentrations of zanidatamab as a function of time post-dosing","definition_or_measurement_approach":"PK sampling to assess serum concentration vs time"}
  • {"endpoint_text":"- Frequency, duration, and time of onset of antizanidatamab antibodies and neutralizing antibodies, if applicable, to zanidatamab","definition_or_measurement_approach":"Immunogenicity assessments (anti-drug antibodies and neutralizing antibodies)"}
  • {"endpoint_text":"- Time to definitive deterioration (TDD) from baseline in the IHC 3+ subgroup in patientreported global health status (GHS) score as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire – Core 30 (QLQC30)","definition_or_measurement_approach":"Patient-reported GHS from EORTC QLQ-C30; time to definitive deterioration measured vs baseline"}
  • {"endpoint_text":"- TDD from baseline in the overall population in patientreported GHS score as measured by the EORTC QLQC30","definition_or_measurement_approach":"Patient-reported GHS from EORTC QLQ-C30; time to definitive deterioration measured vs baseline"}
  • {"endpoint_text":"- Change from baseline in health economics and outcomes research/patient-reported outcome (HEOR/PRO) parameters using the EORTC QLQC30, Quality of Life Questionnaire – Cholangiocarcinoma and Gallbladder Cancer module (QLQ-BIL21), and 5level EuroQol5 Dimension (EQ-5D-5L)","definition_or_measurement_approach":"PRO instruments: EORTC QLQ-C30, QLQ-BIL21, EQ-5D-5L"}

Recruitment

Digital Remote Recruitment
True, digital/remote methods described: Scout email communications and ScoutPass materials, website postings (Docrates), ePRO/LX-Core app screenshots and self-complete/on-site PRO electronic tools (documents L2_... LX-Core-App and PRO screenshots). These indicate use of electronic patient-reported outcome tools and digital study brochures/emails for outreach.
Planned Sample Size
154
Recruitment Window Months
62
Consent Approach
All participants (adults ≥18) must provide written informed consent. A separate written informed consent is required for pre-screening for HER2 status (collection, storage and analysis of tumour tissue). Country- and language-specific subject information sheets and ICFs are provided (numerous ICF documents in English, Romanian, Czech, French, Spanish, Portuguese, German, Swedish, Finnish, Italian, Dutch, etc.). Additional ICFs exist for pregnancy/partner follow-up, pseudoprogression addenda, and optional future research.

Methods

  • HCP flyers (country-specific materials present: e.g., K2_JZP598-302_HCP_Flyer_SWE, K2_JZP598-302_HCP_Flyer_DE) — channel: printed/email outreach to healthcare professionals; target audience: oncologists, GPs, clinical sites; country-specific flyers indicated in document list.
  • Patient trifold/brochures (country-specific: e.g., Patient_Trifold_SWE, Patient_Trifold_DE) — channel: printed/handout materials at clinics; target audience: potential patients and caregivers.
  • GP letters (Italy: K2_JZP598-302_GP-Letter_IT) — channel: letter/email to general practitioners to inform referral pathways; target audience: primary care physicians in Italy.
  • Site/centre website postings (e.g., Web site add_Docrates Cancer Center_FIN) — channel: institutional website updates; target audience: patients seeking information online, country: Finland.
  • Scout/study brochure and Scout email communications (documents titled Scout-Study-Brochure, Scout-Email-Communication) — channel: email and printed study brochures used for outreach/scouting; target audience: patients and referring HCPs (country-specific documents available e.g., CZE, DE).
  • Country-specific recruitment & informed consent procedures documents (K1 files) detailing local recruitment arrangements (e.g., K1 documents for DE, FR, ES, PT, SE, BE, FIN, CZE, ROU) — channel: local site-led recruitment per national procedures; target audience: local patients/HCPs per country.

Geography

Total Number Of Sites
68
Total Number Of Participants
83

Romania

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
102
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Medical Oncology
Contact Person Name
Adina-Emilia Croitoru
Contact Person Email
adina.croitoru09@yahoo.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Centrul de Oncologie
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Bihor
Department Name
Medical Oncology
Contact Person Name
Amalia Hora
Contact Person Email
amaliahora@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
16
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika 2. LF UK a FN Motol
Contact Person Name
Stanislav Batko
Contact Person Email
stanislav.batko@fnmotol.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Contact Person Name
Stanislav John
Contact Person Email
stanislav.john@fnhk.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Contact Person Name
Zdeněk Král
Contact Person Email
kral.zdenek@fnbrno.cz

France

Earliest CTIS Part Ii Submission Date
06-08-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
7
Number Of Sites
12
Number Of Participants
16

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d’oncologie digestive
Contact Person Name
Jean-Frédéric Blanc
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Service d’oncologie-chirurgie digestive
Contact Person Name
Marine Jary
Contact Person Email
mjary@chu-clermontferrand.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology department
Contact Person Name
Jean-Philippe Metges
Site Name
Hopital Beaujon
Department Name
Oncologie hépatique et Innovation Thérapeutique
Contact Person Name
Mohamed Bouattour
Contact Person Email
Mohamed.bouattour@aphp.fr
Site Name
Institut de Cancérologie de l’Ouest
Department Name
Département d’oncologie médicale
Contact Person Name
Dr Amélie Mallet
Contact Person Email
Amelie.mallet@ico.unicancer.fr
Site Name
Besancon University Hospital Center
Department Name
Service ONCOLOGIE Médicale
Contact Person Name
Morgane Stouvenot
Contact Person Email
mstouvenot@chu-besancon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service Oncologie
Contact Person Name
Christophe Tournigand
Contact Person Email
tournigand.christophe@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Oncologie Médicale
Contact Person Name
Eric Assenat
Contact Person Email
e-assenat@chu-montpellier.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Département d’oncologie médicale
Contact Person Name
Judith RAIMBOURG
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie Médicale
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Oncologie Médicale Digestive
Contact Person Name
Nadim Fares
Contact Person Email
fares.n@chu-toulouse.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology Department
Contact Person Name
Michel Ducreux

Spain

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
25
Number Of Sites
15
Number Of Participants
15

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Oncología Médica
Contact Person Name
Teresa MACARULLA MERCADE
Contact Person Email
macarulla@clinic.cat
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncología Médica
Principal Investigator Name
Mariano Ponz-Sarvisé
Principal Investigator Email
mponz@unav.es
Contact Person Name
Mariano Ponz-Sarvisé
Contact Person Email
mponz@unav.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio Oncología Médica
Contact Person Name
Martín Pérez Martelo
Contact Person Email
martin.perez.martelo@sergas.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncología Médica
Contact Person Name
Inmaculada Áles Díaz
Contact Person Email
inales@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología Médica
Contact Person Name
JAUME CAPDEVILA CASTILLON
Contact Person Email
jcapdevila@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología Médica
Contact Person Name
Jorge Adeva Alfonso
Contact Person Email
jorge.adeva@salud.madrid.org
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncología Médica
Principal Investigator Name
Roberto Pedro Díaz Beveridge
Principal Investigator Email
diaz_rob@gva.es
Contact Person Name
Roberto Pedro Díaz Beveridge
Contact Person Email
diaz_rob@gva.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Oncología Médica
Contact Person Name
Mariano Ponz-Sarvisé
Contact Person Email
mponz@unav.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncología Médica
Contact Person Name
Juan José Reina Zoilo
Contact Person Email
juanjoreinaz@yahoo.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncología Médica
Contact Person Name
Angela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncología Médica
Contact Person Name
Rosa María Rodríguez Alonso
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Oncología Médica
Contact Person Name
Roberto Pazo Cid
Contact Person Email
rpazo@salud.aragon.es
Site Name
Hospital Universitario La Paz
Department Name
Oncología Médica
Contact Person Name
Ismael Ghanem Cañete
Contact Person Email
isma_g_c@hotmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz (additional entry)
Department Name
Oncología Médica
Contact Person Name
Angela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital Universitario 12 De Octubre (additional entry)
Department Name
Oncología Médica
Contact Person Name
Jorge Adeva Alfonso
Contact Person Email
jorge.adeva@salud.madrid.org

Sweden

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
28
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Karolinska University Hospital
Department Name
Cancerstudieenheten Huddinge, Hälsovägen 13, Huddinge
Contact Person Name
Maria Gustafsson Liljefors
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Onkologiska mottagningen, Jubileumskliniken, Blå stråket 2, Göteborg
Contact Person Name
Leif Klint
Contact Person Email
Leif.klint@vgregion.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Onkologiska mottagningen, Jan Waldenströms gata 18, Malmö
Contact Person Name
Margareta Heby
Contact Person Email
Margareta.heby@med.lu.se

Belgium

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
12-08-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
Antwerp University Hospital
Department Name
Multidisciplinair Oncologisch Centrum Antwerpen
Contact Person Name
Timon Vandamme
Contact Person Email
timon.vandamme@uza.be
Site Name
UZ Leuven
Department Name
Gastro-enterology
Contact Person Name
Jeroen Dekervel
Contact Person Email
jeroen.dekervel@uzleuven.be
Site Name
Imelda
Department Name
Gastro-enterology
Contact Person Name
Pieter-Jan Cuyle
Contact Person Email
pieter-jan.cuyle@imelda.be

Portugal

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
11-09-2024
Processing Time Days
72
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Champalimaud Clinical Centre
Department Name
Unidade de Digestivos - Champalimaud Foundation
Contact Person Name
Nuno Couto
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Medical Oncology
Contact Person Name
Anabela Barros
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Medical Oncology - Hospital dos Capuchos
Contact Person Name
João Boavida Ferreira
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Isabel Vilas-Boas
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Medical Oncology
Contact Person Name
Helder Mansinho

Germany

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
16-08-2024
Processing Time Days
31
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
Contact Person Name
Anna Saborowski
Contact Person Email
Saborowski.Anna@mh-hannover.de
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Contact Person Name
Michael Dill
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III Station F5b
Contact Person Name
Volker Heinemann
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Virchow Klinikum Medizinische Klinik mit Schwerpunkt Hämatologie/Onkologie und Tumorimmunolog
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Klinik Altona Onkologie und Palliativmedizin mit Sektionen Hämatologie und Rheumatologie
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Campus Lübeck MKI Haus A, OG 1, Raum 87
Contact Person Name
Jens Marquardt
Contact Person Email
Jens.Marquardt@uksh.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Contact Person Name
Thorsten Oliver Götze
Contact Person Email
Info.IKF@khnw.DE
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin II Gastroenterologie / Hepatologie / Endokrinologie / Infektiologie
Contact Person Name
Michael Quante
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik Abt. Innere Medizin I
Contact Person Name
Pavlos Missios
Contact Person Email
IM1CTIS@med.uni-tuebingen.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I, Bereich Klinische Studien
Contact Person Name
Gunnar Folprecht
Contact Person Email
Gunnar.Folprecht@ukdd.de

Italy

Earliest CTIS Part Ii Submission Date
23-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
22
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncoematologia
Contact Person Name
Erika Martinelli
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2 Universitaria
Contact Person Name
Caterina Vivaldi
Contact Person Email
caterinavivaldi@gmail.com
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
U.O. Oncologia Medica 1
Contact Person Name
Annamaria Pessino
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Dipartimento di Oncologia Medica
Contact Person Name
Virginia Quarà
Contact Person Email
virginia.quara@ircc.it
Site Name
Istituto Oncologico Veneto
Department Name
U.O. Oncologia Medica
Contact Person Name
Francesca Bergamo
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Dipartimento di Oncologia
Contact Person Name
Silvio Ken Garattini
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Oncologia
Contact Person Name
Davide Melisi
Contact Person Email
davide.melisi@univr.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Unità Operativa di Oncologia ed Ematologia
Contact Person Name
Silvia Bozzarelli
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
S.C. Oncologia Medica
Contact Person Name
Mario Scartozzi
Contact Person Email
marioscartozzi@unica.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SC Oncologia Medica 1
Contact Person Name
Federica Morano

Finland

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
15-08-2024
Processing Time Days
30
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Pohjois-Savon hyvinvointialue
Department Name
Syöpätautien poliklinikka Sädesairaala
Contact Person Name
Okko Kääriäinen
Site Name
Docrates Oy
Contact Person Name
Tuomo Alanko
Contact Person Email
tuomo.alanko@docrates.com
Site Name
HUS-Yhtymae
Department Name
Comprehensive Cancer Centre
Contact Person Name
Katriina Jalkanen
Contact Person Email
katriina.jalkanen@hus.fi

Sponsor

Primary sponsor

Full Name
Jazz Pharmaceuticals Ireland Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
PPD Development LP
Responsibilities
Monitoring and local/national activities; multiple CRO functions including IRT/IXRS, monitoring, regulatory and other trial operations as listed in sponsor duties.
Name
Almac Clinical Services LLC
Responsibilities
IXRS Services

Third parties

  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"IXRS Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Roche","duties_or_roles":"investigational IVD device(s) expertise","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Roche Diagnostic Solutions; additional laboratory services (codes indicated in sponsor duties)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Multiple CRO responsibilities including monitoring and all local/national activities, and other duties (codes 1,2,4,5,6,7,12,13,14,15 per sponsor duties)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JZP598
Active Substance
ZANIDATAMAB
Modality
Other antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
Not authorised (investigational)
Orphan Designation
Yes
Maximum Dose
Max daily amount listed 2400 mg; max total amount 14400 mg (per product record)
Combination Treatment
Yes

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