Clinical trial • Phase III • Oncology|Gastroenterology

ZANIDATAMAB for Gastroesophageal adenocarcinoma (GEA) | Esophageal adenocarcinoma | Advanced gastric carcinoma

Phase III trial of ZANIDATAMAB for Gastroesophageal adenocarcinoma (GEA) | Esophageal adenocarcinoma | Advanced gastric carcinoma.

Overview

Trial Therapeutic Area
Oncology|Gastroenterology
Trial Disease
Gastroesophageal adenocarcinoma (GEA) | Esophageal adenocarcinoma | Advanced gastric carcinoma
Trial Stage
Phase III
Drug Modality
Bispecific antibody|Monoclonal antibody|Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
03-09-2024
First CTIS Authorization Date
07-10-2024

Trial design

Randomised, open-label, arm a: trastuzumab plus physician's choice of capecitabine plus oxaliplatin (capox) or 5-fluorouracil plus cisplatin (fp). (product information lists trastuzumab dose unit mg/kg with maxdailydoseamount 8 mg/kg in the registry entry; no full dosing schedule provided in the public ctis data.)-controlled, adaptive Phase III trial in Romania, Greece, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Trastuzumab plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil plus cisplatin (FP). (Product information lists trastuzumab dose unit mg/Kg with maxDailyDoseAmount 8 mg/Kg in the registry entry; no full dosing schedule provided in the public CTIS data.)
Adaptive
True, interim analyses planned (the primary PFS analysis is performed once target event counts are reached; interim analyses of OS are planned at that time). No dose-escalation rules described in the public record.
Target Sample Size
668
Trial Duration For Participant
756

Eligibility

Recruits 668 The trial record indicates isVulnerablePopulationSelected = true and dedicated subject information and consent forms exist for Pregnant-Partner (documents titled 'Pregnant-Partner-ICF' in multiple languages) as well as prescreening and treatment-through-progression ICFs. Informed consent is handled via Main-ICF documents and separate Pregnant-Partner ICFs (available in multiple country-specific translations)..

Vulnerable Population
The trial record indicates isVulnerablePopulationSelected = true and dedicated subject information and consent forms exist for Pregnant-Partner (documents titled 'Pregnant-Partner-ICF' in multiple languages) as well as prescreening and treatment-through-progression ICFs. Informed consent is handled via Main-ICF documents and separate Pregnant-Partner ICFs (available in multiple country-specific translations).

Inclusion criteria

  • {"criterion_text":"- 1.Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISHpositivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment."}
  • {"criterion_text":"- 2.Assessable (measurable or non-measurable) disease as defined by RECIST 1.1."}
  • {"criterion_text":"- 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization"}
  • {"criterion_text":"- 4.Adequate organ function"}
  • {"criterion_text":"- 5.Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)"}

Exclusion criteria

  • {"criterion_text":"- 1.Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEA."}
  • {"criterion_text":"- 2.Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways."}
  • {"criterion_text":"- 3. Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unrespectable locally advanced, recurrent or metastatic GEA. "}
  • {"criterion_text":"- 4.Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsantsand are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)."}
  • {"criterion_text":"- 5.Known history of or ongoing leptomeningeal disease (LMD)."}
  • {"criterion_text":"- 6.Known additional malignancy that is not considered cured or that has required treatment within the past 3 years. "}
  • {"criterion_text":"- 7.Known active hepatitis"}
  • {"criterion_text":"- 8.Any history of human immunodeficiency virus (HIV) infection"}
  • {"criterion_text":"- 9.Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible"}
  • {"criterion_text":"- 10.Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF). "}
  • {"criterion_text":"- 11.QTc Fridericia (QTcF) > 470 ms."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ●Progression-free survival (PFS) by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), assessed by blinded independent central review (BICR)","definition_or_measurement_approach":"PFS assessed per RECIST v1.1 by blinded independent central review (BICR)."}
  • {"endpoint_text":"- ●Overall survival (OS) The primary PFS analysis will be performed once the target event count has been reached for each comparison. This is estimated to occur 7 months after the last subject is randomized. At this time, interim analyses of OS will be performed.","definition_or_measurement_approach":"Overall survival (OS); primary PFS analysis performed when target event count reached for each comparison (estimated ~7 months after last randomization). Interim OS analyses planned at that time."}

Secondary endpoints

  • {"endpoint_text":"- ●Confirmed objective response rate (ORR) by RECIST 1.1, assessed by BICR","definition_or_measurement_approach":"ORR per RECIST 1.1 assessed by blinded independent central review (BICR)."}
  • {"endpoint_text":"- ●Duration of response (DOR) by RECIST 1.1, assessed by BICR","definition_or_measurement_approach":"DOR per RECIST 1.1 assessed by BICR."}
  • {"endpoint_text":"- ●PFS by RECIST 1.1, per investigator assessment","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by the investigator (investigator assessment)."}
  • {"endpoint_text":"- ●Change from baseline in health economics and outcomes research / patient-reported outcomes (HEOR/PRO) parameters","definition_or_measurement_approach":"Change from baseline in HEOR/PRO parameters (instruments referenced in protocol documents such as QLQ-C30, OG25, EQ-5D-5L where applicable)."}
  • {"endpoint_text":"- ●Serum concentration and PK parameters for zanidatamab","definition_or_measurement_approach":"Serum concentration measurements and pharmacokinetic (PK) parameters for zanidatamab (sampling and PK analysis as per protocol)."}
  • {"endpoint_text":"- ●Serum concentrations for tislelizumab","definition_or_measurement_approach":"Serum concentration measurements for tislelizumab (PK sampling as described in protocol)."}

Recruitment

Registry Or Advocacy Recruitment
True - Patient Advocacy Groups (PAGs) outreach materials are listed (country-specific PAG outreach information documents).
Planned Sample Size
668
Recruitment Window Months
67
Consent Approach
Informed consent is obtained using Main-ICF documents (subject information and informed consent forms) and additional ICFs where applicable (Prescreening-ICF, Pregnant-Partner-ICF, Treatment-through-progression ICF). Main-ICF and supporting ICFs are available in multiple country-specific languages (examples in the public documents: English, Romanian, Greek, Italian, French, Portuguese, Spanish, Polish, Dutch, German, Estonian, Russian). Consent is provided by the adult participant; dedicated Pregnant-Partner ICFs indicate separate information/consent for pregnant partners where applicable.

Methods

  • Physician referral (Doctor-to-Doctor letters / Referral letters for physicians exist for multiple countries).
  • Site-based recruitment materials: patient flyers and patient newsletters (country-specific patient flyers and short flyers).
  • Pathologist outreach: information letters for pathologists/local labs to identify eligible tumor samples.
  • Patient advocacy outreach: PAG outreach information and materials (documents labelled PAG-Outreach or Patient-Advocacy-Group-Info-letter).
  • Prescreening procedures with dedicated Prescreening ICF documents.

Geography

Total Number Of Sites
67
Total Number Of Participants
251

Romania

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
470
Number Of Sites
8
Number Of Participants
36

Sites

Site Name
Cardiomed S.R.L.
Department Name
Medical Oncology
Contact Person Name
Calin Ioan Cainap
Contact Person Email
calin.cainap@cardiomedcluj.ro
Site Name
Medisprof S.R.L.
Department Name
Medical Oncology
Contact Person Name
Anghel Adrian Udrea
Contact Person Email
adrianudrea@medisprof.ro
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Medical Oncology
Contact Person Name
Bogdan Gafton
Contact Person Email
gaftonbogdan@yahoo.com
Site Name
Onco Clinic Consult S.A.
Department Name
Medical Oncology
Contact Person Name
Patricia Visan
Contact Person Email
p.visan@oncoclinic.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology
Contact Person Name
Tudor-Eliade Ciuleanu
Contact Person Email
tudor_ciuleanu@hotmail.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
Institutul Clinic Fundeni
Department Name
Medical Oncology
Contact Person Name
Adina-Emilia Croitoru
Contact Person Email
adina.croitoru09@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology
Contact Person Name
Tudor-Eliade Ciuleanu
Contact Person Email
tudor_ciuleanu@hotmail.com

Greece

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
548
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic Internal Medicine Department
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Bioclinic S.A.
Department Name
Oncology Department
Contact Person Name
Ioannis Boukovinas
Contact Person Email
ibouk@otenet.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Oncology Department
Contact Person Name
Ippokratis Korantzis
Contact Person Email
ippokratis.korantzis@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
03-04-2026
Processing Time Days
550
Number Of Sites
12
Number Of Participants
34

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Ocologia Medica
Contact Person Name
Silvia Foti
Contact Person Email
foti.silvia@hsr.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia medica
Contact Person Name
Filippo Pietrantonio
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
UO Oncologia Medica
Contact Person Name
Margherita Muratore
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Dipartimento di Oncologia, Ematologia e Medicina Molecolare
Contact Person Name
Salvatore Siena
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica
Contact Person Name
Giampaolo Tortora
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncologia Medica
Contact Person Name
Renato Ferraris
Contact Person Email
renato.ferraris@ircc.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Oncologia Medica
Contact Person Name
Davide Melisi
Contact Person Email
davide.melisi@univr.it
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
UOC Oncologia
Contact Person Name
Alessandro Cappetta
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
SC Oncologia
Contact Person Name
Andrea Spallanzani
Contact Person Email
spallanzani.andrea@aou.mo.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
UO Oncologia Medica
Contact Person Name
Carmine Pinto
Contact Person Email
carmine.pinto@ausl.re.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UOC Oncologia Medica
Contact Person Name
Karim Rihawi
Contact Person Email
karim.rihawi@aosp.bo.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
UO Oncologia Medica 1
Contact Person Name
Annamaria Pessino

France

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
567
Number Of Sites
11
Number Of Participants
41

Sites

Site Name
Institut Bergonie
Department Name
Oncologie Médicale
Contact Person Name
Simon Pernot
Contact Person Email
s.pernot@bordeaux.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d’Oncologie Médicale
Contact Person Name
Romain Cohen
Contact Person Email
romain.cohen@aphp.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service d’Hépato-Gastroentérologie
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Leon Berard
Department Name
Oncologie Médicale
Contact Person Name
Clélia Coutzac
Site Name
Institut Sainte Catherine
Department Name
Service d’Oncologie Médicale
Contact Person Name
Rania Boustany
Contact Person Email
r.boustany@isc84.org
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service d’Hépatogastroentérologie
Contact Person Name
Gael Roth
Contact Person Email
groth@chu-grenoble.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Institut de Cancérologie et d’Imagerie
Contact Person Name
Jean-Philippe Metges
Site Name
Institut De Cancerologie De L Ouest
Department Name
Service d’Oncologie Médicale
Contact Person Name
Judith Raimbourg
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Service d’Oncologie Médicale Digestive
Contact Person Name
Samuel Le Sourd
Contact Person Email
s.lesourd@rennes.unicancer.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Service d’Oncologie Médicale
Contact Person Name
François Ghiringhelli
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service d’Oncologie Médicale Digestive
Contact Person Name
Rosine Guimbaud
Contact Person Email
guimbaud.r@chu-toulouse.fr

Poland

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
554
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Chorób Rozrostowych
Contact Person Name
Magdalena Straszyńska
Contact Person Email
magdaslomka@wp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjan.wyrwicz@pib-nio.pl

Belgium

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
548
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
UZ Leuven
Department Name
Digestive Oncology
Contact Person Name
Filip Van Herpe
Contact Person Email
filip.vanherpe@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Digestive Oncology
Contact Person Name
Karen Geboes
Contact Person Email
karen.geboes@uzgent.be
Site Name
Centre Hospitalier Universitaire De Liege
Department Name
Medical Oncology
Contact Person Name
Joëlle Collignon
Contact Person Email
joelle.collignon@chuliege.be

Spain

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
554
Number Of Sites
13
Number Of Participants
67

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology department
Contact Person Name
Rosa Querol Pascual
Contact Person Email
rquerol@tauli.cat
Site Name
Institut Catala D'oncologia
Department Name
Oncology department
Contact Person Name
Raquel Guardeño
Contact Person Email
rguardeno@iconcologia.net
Site Name
Hospital Universitario La Paz
Department Name
Oncology department
Contact Person Name
Ana Custodio
Contact Person Email
anabcustodio@gmail.com
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncology department
Contact Person Name
Roberto Bouzo (Ioannis Boukovinas?)
Contact Person Email
rpazo@salud.aragon.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology department
Contact Person Name
Juan José Reina Zoilo
Contact Person Email
juanjoreinaz@yahoo.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology department
Contact Person Name
Federico Longo Muñoz
Contact Person Email
fedelongomunoz@hotmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
Oncology department
Contact Person Name
Rosario Vidal Tocino
Contact Person Email
mrvidal@saludcastillayleon.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology department
Contact Person Name
Josep Tabernero Caturla
Contact Person Email
jtabernero@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
Oncology department
Contact Person Name
Mariona Calvo Campos
Contact Person Email
mcalvo@iconcologia.net
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Oncology department
Contact Person Name
Cinta Hierro Carbo
Contact Person Email
chierro@iconcologia.net
Site Name
Hospital Universitario De Navarra
Department Name
Oncology department
Contact Person Name
Virginia Arrazubi Arrula
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology department
Contact Person Name
Fernando Rivera Herrero
Contact Person Email
fernando.rivera@scsalud.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology department
Contact Person Name
Inmaculada Ales
Contact Person Email
inales@hotmail.com

Ireland

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
555
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
St James's Hospital
Department Name
Cancer Clinical Trials Office
Contact Person Name
Maeve Lowery
Contact Person Email
milowery@tcd.ie

Germany

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
549
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch Onkologische Forschung
Contact Person Name
Thorsten Götze
Contact Person Email
goetze.thorsten@khnw.de

Netherlands

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
549
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Contact Person Name
Robbert Jeroen van Alphen
Contact Person Email
r.vanalphen@etz.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Contact Person Name
Marije Slingerland
Contact Person Email
m.slingerland@lumc.nl
Site Name
Catharina Ziekenhuis Stichting
Contact Person Name
Irene Van-Hellemond

Portugal

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
549
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Filipa Carneiro
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Oncology
Contact Person Name
Fabio Lopes
Contact Person Email
fabio.lopes@hbeatrizangelo.pt
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Oncology
Contact Person Name
Sérgio Azevedo
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Oncology
Contact Person Name
Carolina Carvalho
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Immunohemotherapy
Contact Person Name
Paula Jacinto
Contact Person Email
17835@chuc.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Medical Oncology
Contact Person Name
Cecília Alvim
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Oncology
Contact Person Name
Helena Magalhães
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Oncology
Contact Person Name
Helder Mansinho

Estonia

Earliest CTIS Part Ii Submission Date
30-09-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
569
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
North Estonia Medical Centre Foundation
Department Name
Oncology and Haematology Clinic
Contact Person Name
Niina Kippasto

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
Name
Almac Clinical Services LLC
Responsibilities
IXRS for treatment randomization and IP management
Name
Cytel Inc.
Responsibilities
IDMC

Third parties

  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"long term sample storage","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"IDMC","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"HER2 testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"patient accommodation, ground transportation and expense management services","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Local Lab Data Entry","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"collect EMEA PK ADA samples and distribute to Indianapolis; HER2 testing","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"PK Testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA testing","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":"Almac Clinical Services LLC","duties_or_roles":"IXRS for treatment randomization and IP management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing; Histopathology; Primary/ surrogate endpoint test, PK and ADA analysis, HER2","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc. Primary/ surrogate endpoint test Central Image Reader","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Finland","full_name":"Optimapharm Nordic Oy","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"PD-L1 testing","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
JZP598
Active Substance
ZANIDATAMAB
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus 1 (investigational / sponsor product PRD10444188 listed)
Orphan Designation
Yes
Maximum Dose
2400 mg (maxTotalDoseAmount)
Investigational Product Name
Tislelizumab
Active Substance
TISLELIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Investigational (productDictionaryInfo indicates investigational product PRD5423108)
Maximum Dose
200 mg (maxTotalDoseAmount)
Investigational Product Name
TRASTUZUMAB
Active Substance
TRASTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorized/marketed biologic (prodAuthStatus 2 listed in productDictionaryInfo)
Maximum Dose
8 mg/Kg (maxDailyDoseAmount/maxTotalDoseAmount indicated as 8 mg/Kg)
Investigational Product Name
Oxaliplatin 5 mg/ml concentrate for solution for infusion
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
Authorised (marketing authorisation PL 31750/0048 noted)
Maximum Dose
130 mg/m2 daily (maxDailyDoseAmount) (dose unit mg/m2)
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketed (prodAuthStatus 2 listed in productDictionaryInfo)
Maximum Dose
2000 mg/m2 (maxDailyDoseAmount)
Investigational Product Name
LOPERAMIDE
Active Substance
LOPERAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketed (listed as auxiliary / marketed drug)
Maximum Dose
8 mg (maxDailyDoseAmount)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.