Clinical trial • Phase III • Oncology

Humanised IgG1 monoclonal antibody against human epidermal growth factor receptor 2 for Gastroesophageal junction cancer | Gastric cancer

Phase III trial of Humanised IgG1 monoclonal antibody against human epidermal growth factor receptor 2 for Gastroesophageal junction cancer | Gastric canc…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastroesophageal junction cancer | Gastric cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
08-01-2025
First CTIS Authorization Date
22-04-2025

Trial design

Randomised, trastuzumab + chemotherapy (xelox) with or without pembrolizumab. placebo arms include placebo_pembrolizumab and placebo_hlx22. (specific doses/schedules not provided in the ctis summary.)-controlled Phase III trial in Romania, Portugal, Greece and others.

Randomised
Yes
Comparator
Trastuzumab + chemotherapy (XELOX) with or without pembrolizumab. Placebo arms include placebo_pembrolizumab and placebo_HLX22. (Specific doses/schedules not provided in the CTIS summary.)
Target Sample Size
444

Eligibility

Recruits 444 No vulnerable populations selected. Participants must be ≥18 years of age (or the country’s minimal age of maturity). Participation is voluntary and participants must have signed the informed consent form (ICF). No assent procedures for minors are applicable as only adults are eligible..

Pregnancy Exclusion
Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before randomization.
Vulnerable Population
No vulnerable populations selected. Participants must be ≥18 years of age (or the country’s minimal age of maturity). Participation is voluntary and participants must have signed the informed consent form (ICF). No assent procedures for minors are applicable as only adults are eligible.

Inclusion criteria

  • {"criterion_text":"- Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the ICF; willing to comply with and able to complete all trial procedures.\n- HIV antibody (–); if HIV antibody (+), the subject should receive antiretroviral therapy for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.\n- Has adequate organ function as defined in the protocol.\n- Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before randomization. Female subjects of childbearing potential and male subjects with female partners of childbearing potential have to adopt at least one highly effective contraceptive measure as defined by Clinical Trials Facilitation Group（CTFG） (such as intra-uterine contraceptive device, contraceptive pill or condom, female/male sterilization, etc.) during the study treatment period, and at least 9 months after the last dose of study treatment.\n- Male or female who is at least 18 years of age or a country’s minimal age of maturity or greater on the day of signing the informed consent.\n- With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.\n- Has measurable disease as assessed by BICR according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, the target lesion must not be a bone metastatic lesion only.\n- HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH+, as assessed by a central laboratory on a primary or metastatic tumor.\n- ECOG PS within 7 days before randomization: 0-1.\n- Expected survival ≥ 6 months.\n- Hepatitis B surface antigen (HBsAg) (–) and hepatitis B core antibody (HBcAb) (–); if HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be < 2,500 copies/mL or 500 IU/mL or within the normal range of this site (And if the site has a normal range, HBV-DNA should be within the range of the site).\n- HCV antibody (–); if HCV antibody (+), HCV-RNA testing must be negative before enrollment. Subjects co-infected with hepatitis B and C will be excluded (tested positive for HBsAg or HBcAb and positive for HCV antibody)."}

Exclusion criteria

  • {"criterion_text":"- Subjects with other malignant tumors within 2 years before the randomization. Subjects with localized tumors that have been resolved, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, and thyroid carcinoma, may be enrolled.\n- Subjects with history or complicated interstitial lung disease, an active infection requiring systemic therapy or active tuberculosis.\n- Subjects who received live vaccines within 28 days prior to randomization; except for seasonal influenza or inactivated COVID-19 vaccines.\n- Subjects who had a major surgery within 28 days prior to the randomization.\n- Subjects who received radical radiotherapy within 28 days prior to the randomization.\n- Subjects who were participating in or had participated in a study of an investigational agent or had used an investigational device within 28 days prior to the randomization.\n- Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.\n- Subjects who had a known history of psychotropic drug abuse or drug addiction.\n- Lactating subject.\n- Known dihydropyrimidine dehydrogenase deficiency or current use of antiviral drug sorivudine or its chemically related analogs, such as brivudine.\n- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n- Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma.. Patient may have received prior perioperative therapy (neoadjuvant or adjuvant therapy) as long as it was completed at least 6 months prior to randomization and without progression.\n- Prior use of doxorubicin with in vivo concentrations > 360 mg/m2 (or equivalent) as described in the protocol.\n- Previous treatment with any HER2-target therapy.\n- Residual toxicity resulting from previous therapy. Alopecia is permitted.\n- Active gastrointestinal bleeding (Grade ≥ 2 according to National Cancer Institute [NCI] CTCAE v5.0).\n- Presence of central nervous system (CNS) metastases and/or leptomeningeal disease.\n- Occurrence of cerebrovascular accidents, myocardial infarction, unstable angina and poorly controlled arrhythmia (including QTc interval ≥ 470 ms) (QTc interval calculated according to the Fridericia formula) within half a year prior to the randomization.\n- According to the New York Heart Association (NYHA) classification, subjects with class III or IV cardiac insufficiency or color Doppler echocardiogram (ECHO): left ventricular ejection fraction (LVEF) < 55%."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) (assessed by the Blinded Independent Central Review [BICR] per RECIST v1.1).","definition_or_measurement_approach":"Assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1."}
  • {"endpoint_text":"- Overall survival (OS).","definition_or_measurement_approach":"Overall survival (time from randomization to death from any cause)."}

Secondary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) (assessed by investigator per RECIST v1.1).","definition_or_measurement_approach":"Assessed by investigator according to RECIST v1.1."}
  • {"endpoint_text":"- Objective response rate (ORR) (assessed by BICR and investigator per RECIST v1.1).","definition_or_measurement_approach":"Assessed by both BICR and investigator per RECIST v1.1."}
  • {"endpoint_text":"- Progression-free survival on next line of therapy (PFS2) (assessed by investigator per RECIST v1.1)","definition_or_measurement_approach":"Assessed by investigator according to RECIST v1.1 for next-line therapy."}
  • {"endpoint_text":"- Duration of response (DOR) (assessed by BICR and investigator per RECIST v1.1).","definition_or_measurement_approach":"Assessed by BICR and investigator per RECIST v1.1 (time from first documented response to progression or death)."}
  • {"endpoint_text":"- Incidence of adverse events (AEs) and serious adverse events (SAEs).","definition_or_measurement_approach":"Safety reporting according to CTCAE and study safety procedures (incidence and severity of AEs/SAEs)."}
  • {"endpoint_text":"- PK: concentration of HLX22 in serum.","definition_or_measurement_approach":"Pharmacokinetic measurement of HLX22 serum concentration."}
  • {"endpoint_text":"- Immunogenicity evaluation: incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) of HLX22.","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against HLX22 will be measured."}
  • {"endpoint_text":"- Quality of life assessment.","definition_or_measurement_approach":"Quality of life instruments (e.g., QLQ-C30, QLQ-STO22, EQ-5D-5L) as per patient-facing documents."}

Recruitment

Planned Sample Size
444
Recruitment Window Months
40
Consent Approach
Informed consent is obtained from each participant; participants must sign the ICF ('has signed the ICF' is stated). Consent documents (SIS and ICF and related ICF variants) are available in multiple languages (English, Romanian, Greek, Spanish, Italian, Polish, Portuguese and others) as reflected by the patient-facing document set. Only adults (≥18 years or country age of majority) are eligible, so no assent for minors is applicable.

Methods

  • Advertisements for subject recruitment (K2 recruitment materials) — patient-directed advertisements/advertising (languages and country-specific versions available).
  • Clinical trial listing documents — public listing of the trial for patient/HCP awareness.
  • Dr_to_Dr letters — HCP outreach to inform referring physicians about the study.
  • Patient brochures and patient visit guides — informational materials provided to potential participants.
  • HCP posters and GP letters — materials targeted to healthcare professionals to support recruitment.
  • Chart review checklists and IE cards — site-level tools to identify potential participants and support enrolment.

Geography

Total Number Of Sites
53
Total Number Of Participants
106

Romania

Earliest CTIS Part Ii Submission Date
24-01-2025
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
383
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Department Name
Oncology
Principal Investigator Name
Radu Vidra
Principal Investigator Email
irgh@irgh.ro
Contact Person Name
Radu Vidra
Contact Person Email
irgh@irgh.ro
Site Name
Sigmedical Services S.R.L.
Department Name
Oncology
Principal Investigator Name
Doina Elena Ganea
Principal Investigator Email
motan_doina@yahoo.com
Contact Person Name
Doina Elena Ganea
Contact Person Email
motan_doina@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncology
Principal Investigator Name
Michael Schenker
Principal Investigator Email
mike_schenker@yahoo.com
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncology
Principal Investigator Name
Andrei Ungureanu
Principal Investigator Email
andrei.ungureanu@amethyst-radiotherapy.com
Contact Person Name
Andrei Ungureanu
Site Name
Pelican Impex S.R.L.
Department Name
Oncology
Principal Investigator Name
Ioana Ciurescu
Principal Investigator Email
ioana_covaciu@yahoo.com
Contact Person Name
Ioana Ciurescu
Contact Person Email
ioana_covaciu@yahoo.com

Portugal

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
207
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Hospital Cuf Tejo S.A.
Department Name
Oncology
Principal Investigator Name
Ana Raimundo
Principal Investigator Email
ana.c.raimundo@cuf.pt
Contact Person Name
Ana Raimundo
Contact Person Email
ana.c.raimundo@cuf.pt
Site Name
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Department Name
Oncology
Principal Investigator Name
Antonio Teira
Principal Investigator Email
ateira@chtmad.min-saude.pt
Contact Person Name
Antonio Teira
Contact Person Email
ateira@chtmad.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Oncology
Principal Investigator Name
Catarina Abreu
Principal Investigator Email
catarinaabreupm@gmail.com
Contact Person Name
Catarina Abreu
Contact Person Email
catarinaabreupm@gmail.com
Site Name
Lusiadas S.A.
Department Name
Oncology
Principal Investigator Name
Ricardo Martins da Luz
Principal Investigator Email
ricardo.martins.luz@lusiadas.pt
Contact Person Name
Ricardo Martins da Luz

Greece

Earliest CTIS Part Ii Submission Date
04-08-2025
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
191
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Department of Medical Oncology, Aristotle University of Thessaloniki
Principal Investigator Name
Eleni Timotheadou
Principal Investigator Email
timotheadoue@gmail.com
Contact Person Name
Eleni Timotheadou
Contact Person Email
timotheadoue@gmail.com
Site Name
Saint Savvas Oncology Hospital
Department Name
2nd Pathology department
Principal Investigator Name
Dimitrios Tryfonopoulos
Principal Investigator Email
tryfonopoulos@hotmail.com
Contact Person Name
Dimitrios Tryfonopoulos
Contact Person Email
tryfonopoulos@hotmail.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department, Psychiko Branch
Principal Investigator Name
Michalis Karamouzis
Principal Investigator Email
mkaramouz@med.uoa.gr
Contact Person Name
Michalis Karamouzis
Contact Person Email
mkaramouz@med.uoa.gr
Site Name
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department Name
Department of Medical Oncology
Principal Investigator Name
Eleni Res
Principal Investigator Email
nellieres@yahoo.gr
Contact Person Name
Eleni Res
Contact Person Email
nellieres@yahoo.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Dept of Internal Medicine and Laboratory
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
10-04-2025
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
306
Number Of Sites
10
Number Of Participants
16

Sites

Site Name
Klinikum St Marien Amberg
Department Name
Studienzentrum
Principal Investigator Name
Ludwig Fischer von Weikersthal
Principal Investigator Email
weikersthal.ludwig@klinikum-amberg.de
Contact Person Name
Ludwig Fischer von Weikersthal
Site Name
Medizinische Hochschule Hannover
Department Name
Dept. of Gastroenterology, Hepatology and Endocrinology
Principal Investigator Name
Thomas Wirth
Principal Investigator Email
wirth.thomas@mh-hannover.de
Contact Person Name
Thomas Wirth
Contact Person Email
wirth.thomas@mh-hannover.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik Ill
Principal Investigator Name
Julian Holch
Principal Investigator Email
Julian.Holch@med.uni-muenchen.de
Contact Person Name
Julian Holch
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Klinik fuer Innere Medizin III
Principal Investigator Name
Uwe Martens
Principal Investigator Email
uwe.martens@slk-kliniken.de
Contact Person Name
Uwe Martens
Contact Person Email
uwe.martens@slk-kliniken.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik fuer lnnere Medizin II Abteilung Haematologie und lnternistische Onkologie
Principal Investigator Name
Udo Lindig
Principal Investigator Email
Udo.lindig@med.uni-jena.de
Contact Person Name
Udo Lindig
Contact Person Email
Udo.lindig@med.uni-jena.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik fuer Internistische Onkologie
Principal Investigator Name
Christian Mueller
Principal Investigator Email
ch.mueller@kliniken-essen-mitte.de
Contact Person Name
Christian Mueller
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Klinik fuer Innere Medizin, Onkologie, Haematologie und Palliativmedizin
Principal Investigator Name
Florian Weissinger
Principal Investigator Email
Florian.Weissinger@evkb.de
Contact Person Name
Florian Weissinger
Contact Person Email
Florian.Weissinger@evkb.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Gunnar Folprecht
Principal Investigator Email
gunnar.folprecht@uniklinikum-dresden.de
Contact Person Name
Gunnar Folprecht
Site Name
Kreiskliniken Reutlingen gGmbH
Department Name
Department of Internal Medicine I
Principal Investigator Name
Stefan Kubicka
Principal Investigator Email
Stefan.kubicka@kliniken-rt.de
Contact Person Name
Stefan Kubicka
Contact Person Email
Stefan.kubicka@kliniken-rt.de
Site Name
Haematologisch-Onkologische Praxis Eppendorf (HOPE)
Department Name
Norddeutsches Studienzentrum fuer Innovative Onkologie (NIO)
Principal Investigator Name
Alexander Stein
Principal Investigator Email
stein@hope-hamburg.de
Contact Person Name
Alexander Stein
Contact Person Email
stein@hope-hamburg.de

Italy

Earliest CTIS Part Ii Submission Date
18-04-2025
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
294
Number Of Sites
9
Number Of Participants
15

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Operative Unit of Oncology and Hematology
Principal Investigator Name
Armando Santoro
Principal Investigator Email
armando.santoro@cancercenter.humanitas.it
Contact Person Name
Armando Santoro
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2 Universitaria
Principal Investigator Name
Lorenzo Fornaro
Principal Investigator Email
lorenzo.fornaro@gmail.com
Contact Person Name
Lorenzo Fornaro
Contact Person Email
lorenzo.fornaro@gmail.com
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
SC Oncologia
Principal Investigator Name
Maddalena Mancin
Principal Investigator Email
mmancin@asst-pg23.it
Contact Person Name
Maddalena Mancin
Contact Person Email
mmancin@asst-pg23.it
Site Name
Azienda Ospedaliera Sant'anna E San Sebastiano Di Caserta
Department Name
Oncohematology
Principal Investigator Name
Michele Orditura
Principal Investigator Email
michele.orditura@aorncaserta.it
Contact Person Name
Michele Orditura
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncoematologia
Principal Investigator Name
Ferdinando De Vita
Principal Investigator Email
ferdinando.devita@unicampania.it
Contact Person Name
Ferdinando De Vita
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
Oncology
Principal Investigator Name
Giulia Grizzi
Principal Investigator Email
giulia.grizzi@asst-cremona.it
Contact Person Name
Giulia Grizzi
Contact Person Email
giulia.grizzi@asst-cremona.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Oncology Department
Principal Investigator Name
Giuseppe Aprile
Principal Investigator Email
giuseppe.aprile@asufc.sanita.fvg.it
Contact Person Name
Giuseppe Aprile
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medicina Interna – SOD Clinica Oncologica
Principal Investigator Name
Rossana Berardi
Principal Investigator Email
rossana.berardi@ospedaliriuniti.marche.it
Contact Person Name
Rossana Berardi
Site Name
Casa Sollievo Della Sofferenza
Department Name
Oncologia
Principal Investigator Name
Tiziana Pia Latiano
Principal Investigator Email
t.latiano@operapadrepio.it
Contact Person Name
Tiziana Pia Latiano
Contact Person Email
t.latiano@operapadrepio.it

Spain

Earliest CTIS Part Ii Submission Date
10-04-2025
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
305
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Maria Luisa Limon Miron
Principal Investigator Email
mluisalimon@gmail.com
Contact Person Name
Maria Luisa Limon Miron
Contact Person Email
mluisalimon@gmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Principal Investigator Name
Paula Jimenez Fonseca
Principal Investigator Email
palucaj@hotmail.com
Contact Person Name
Paula Jimenez Fonseca
Contact Person Email
palucaj@hotmail.com
Site Name
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Department Name
Oncology
Principal Investigator Name
Tania Fleitas
Principal Investigator Email
tfleitas@incliva.es
Contact Person Name
Tania Fleitas
Contact Person Email
tfleitas@incliva.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Antonio Sanchez Ruiz
Principal Investigator Email
acsr71@hotmail.com
Contact Person Name
Antonio Sanchez Ruiz
Contact Person Email
acsr71@hotmail.com
Site Name
Hospital Del Mar
Department Name
Oncology
Principal Investigator Name
Laura Visa Turmo
Principal Investigator Email
61301@parcdesalutmar.cat
Contact Person Name
Laura Visa Turmo
Contact Person Email
61301@parcdesalutmar.cat
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Principal Investigator Name
Ana Belen Custodio Carretero
Principal Investigator Email
anabcustodio@gmail.com
Contact Person Name
Ana Belen Custodio Carretero
Contact Person Email
anabcustodio@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Mariona Calvo Campos
Principal Investigator Email
mcalvo@iconcologia.net
Contact Person Name
Mariona Calvo Campos
Contact Person Email
mcalvo@iconcologia.net
Site Name
Hospital Alvaro Cunqueiro
Department Name
Oncology
Principal Investigator Name
Paula Gonzalez Villarroel
Principal Investigator Email
Paula.gonzalez.villarroel@sergas.es
Contact Person Name
Paula Gonzalez Villarroel
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Pilar Aitana Calvo Ferrandiz
Principal Investigator Email
aitanacalvo@hotmail.com
Contact Person Name
Pilar Aitana Calvo Ferrandiz
Contact Person Email
aitanacalvo@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
24-04-2025
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
291
Number Of Sites
11
Number Of Participants
25

Sites

Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Oddzial Terapii Izotopowej
Principal Investigator Name
Ewa Kosakowska
Principal Investigator Email
ewa.kosakowska@pimmswia.gov.pl
Contact Person Name
Ewa Kosakowska
Contact Person Email
ewa.kosakowska@pimmswia.gov.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Lucjan Wyrwicz
Principal Investigator Email
lucjan.wyrwicz@nio.gov.pl
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjan.wyrwicz@nio.gov.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Oddzial Onkologii Klinicznej
Principal Investigator Name
Tomasz Ciszewski
Principal Investigator Email
tomek.ciszewski@wp.pl
Contact Person Name
Tomasz Ciszewski
Contact Person Email
tomek.ciszewski@wp.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Oddzial‚ Kliniczny Onkologii B
Principal Investigator Name
Adrianna Makarewicz
Principal Investigator Email
makarewicza@co.bydgoszcz.pl
Contact Person Name
Adrianna Makarewicz
Contact Person Email
makarewicza@co.bydgoszcz.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Principal Investigator Name
Dariusz Sawka
Principal Investigator Email
dyronk@szpital-brzozow.pl
Contact Person Name
Dariusz Sawka
Contact Person Email
dyronk@szpital-brzozow.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddzial Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
Sekretariat.odch@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
Sekretariat.odch@swk.med.pl
Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej i Chemioterapii
Principal Investigator Name
Cezary Szczylik
Principal Investigator Email
drwasilewska@careaccess.com
Contact Person Name
Cezary Szczylik
Contact Person Email
drwasilewska@careaccess.com
Site Name
Ip Clinic Sp. z o.o.
Principal Investigator Name
Malgorzata Ulanska
Principal Investigator Email
malgorzata.ulanska@ipclinic.pl
Contact Person Name
Malgorzata Ulanska
Contact Person Email
malgorzata.ulanska@ipclinic.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej, Chemioterapii, Badan Klinicznych
Principal Investigator Name
Wojciech Rogowski
Principal Investigator Email
wrogow@amg.gda.pl
Contact Person Name
Wojciech Rogowski
Contact Person Email
wrogow@amg.gda.pl
Site Name
Aidport Sp. z o.o.
Principal Investigator Name
Renata Szoszkiewicz
Principal Investigator Email
renata.szoszkiewicz@aidport.pl
Contact Person Name
Renata Szoszkiewicz
Contact Person Email
renata.szoszkiewicz@aidport.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii I Radioterapii
Principal Investigator Name
Piotr Wysocki
Principal Investigator Email
piotr.wysocki@gumed.edu.pl
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@gumed.edu.pl

Sponsor

Primary sponsor

Full Name
Shanghai Henlius Biotech Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
China

Contract research organisations

Name
Syneos Health Hellas Single Member S.A.
Responsibilities
Operational and vendor responsibilities (sponsorDuties codes: [1,11,12,13,2,5])
Name
Syneos Health Romania S.R.L.
Responsibilities
Operational and vendor responsibilities (sponsorDuties codes: [1,11,12,13,2,5])
Name
Syneos Health UK Limited
Responsibilities
Operational and vendor responsibilities (sponsorDuties codes: [1,11,12,13,2,5])
Name
Q Squared Solutions Limited
Responsibilities
PD-L1 & Her2 testing; laboratory services

Third parties

  • {"country":"China","full_name":"Calyx China Co. Ltd.","duties_or_roles":"sponsorDuties codes: [3]; contact: martin.preis@calyx.ai","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"PD-L1 &Her2 testing (value) and sponsorDuties code 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: [1,11,12,13,2,5] (operational/vendor responsibilities as listed in CTIS entry)","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"Central imaging (sponsorDuties code 15; value: Central imaging)","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Shanghai Henlius Biologics Co. Ltd.","duties_or_roles":"PK, ADA/Nab testing (sponsorDuties value) and code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Romania","full_name":"Syneos Health Romania S.R.L.","duties_or_roles":"sponsorDuties codes: [1,11,12,13,2,5] (operational/vendor responsibilities)","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Nanjing Powerstat Medical Technology Co. Ltd.","duties_or_roles":"IDMC (sponsorDuties value)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"sponsorDuties codes: [1,11,12,13,2,5] (operational/vendor responsibilities)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection (HLX22)
Active Substance
Humanised IgG1 monoclonal antibody against human epidermal growth factor receptor 2
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Investigational (prodAuthStatus=1)
Maximum Dose
15 mg/kg
Investigational Product Name
PEMBROLIZUMAB
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Marketing authorisation status present in productDictionaryInfo (prodAuthStatus=2) for the substance entry
Maximum Dose
200 mg
Investigational Product Name
placebo_pembrolizumab
Modality
Other
Investigational Product Name
placebo_HLX22
Modality
Other
Combination Treatment
Yes

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