Clinical trial • Phase III • Oncology

AZD0901 for Gastric cancer | Gastroesophageal junction adenocarcinoma (Claudin 18.2 positive)

Phase III trial of AZD0901 for Gastric cancer | Gastroesophageal junction adenocarcinoma (Claudin 18.2 positive).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastric cancer | Gastroesophageal junction adenocarcinoma (Claudin 18.2 positive)
Trial Stage
Phase III
Drug Modality
ADC | Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
28-03-2024
First CTIS Authorization Date
25-07-2024

Trial design

Randomised, open-label, investigator's choice of therapy consisting of approved standard agents: lonsurf (trifluridine/tipiracil) 15 mg/6.14 mg or 20 mg/8.19 mg film-coated tablets (oral); cyramza (ramucirumab) 10 mg/ml concentrate for infusion (iv); paclitaxel (solution for infusion); docetaxel (concentrate for infusion); irinotecan (concentrate for infusion). specific dosing schedules not specified in the ctis record.-controlled Phase III trial across 44 sites in Germany, Poland, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator's choice of therapy consisting of approved standard agents: Lonsurf (trifluridine/tipiracil) 15 mg/6.14 mg or 20 mg/8.19 mg film-coated tablets (oral); Cyramza (ramucirumab) 10 mg/ml concentrate for infusion (IV); Paclitaxel (solution for infusion); Docetaxel (concentrate for infusion); Irinotecan (concentrate for infusion). Specific dosing schedules not specified in the CTIS record.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
472

Eligibility

Recruits 472 adults.

Inclusion criteria

  • {"criterion_text":"- Participant must be at least 18 years or the legal age of consent in the jurisdiction\n- Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement a) With positive CLDN 18.2 expression determined by central lab. For participants who have received prior CLDN18.2 targeting therapies a new biopsy upon progression must be provided for testing to determine CLDN18.2 expression.\n- Disease progression on or after at least one prior line of treatment (LoT), which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.\n- Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1\n- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n- Predicted life expectancy of ≥ 12 weeks\n- Adequate organ and bone marrow function as show in table in full CSP\n- Body weight of ≥ 35 kg\n- Sex and contraceptive requirements"}

Exclusion criteria

  • {"criterion_text":"- Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine the eligibility.\n- Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.\n- CNS metastases or CNS pathology including: epilepsy, seizures, or aphasia within 3 months prior to consent, severe brain injury, dementia, Parkinson’s disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases. The following are exceptions to this criterion: (a) Participants with history of seizures are permitted if no active seizures in last 5 years. (b) Participants with brain metastases treated, asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to randomization. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrolment.\n- Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).\n- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).\n- Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc).\n- History of thromboembolic events\n- As judged by the Investigator, any evidence of diseases which in the Investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS in all randomized participants (BICR)\n- OS for 3L+ participants","definition_or_measurement_approach":"PFS in all randomized participants assessed by BICR (Blinded Independent Central Review). OS for 3L+ participants defined as overall survival (time from randomization to death from any cause)."}

Secondary endpoints

  • {"endpoint_text":"- OS in all - time from randomization until the date of death due to any cause.\n- PFS for 3L+ participants- time from randomization until progression per RECIST 1.1 asassessed by BICR or death due to any cause.\n- ORR in all- the proportion of participants with at least one visit response of confirmed CR or confirmed PR, as determined by BICR per RECIST 1.1.\n- ORR for 3L+ participants\n- DoR in all- the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.\n- DoR for 3L+ participants\n- Serum concentrations of AZD0901, total antibody and MMAE, and PK parameters\n- Presence of ADAs against AZD0901 in serum\n- Incidence of AEs and SAEs.","definition_or_measurement_approach":"OS: time from randomization to death from any cause. PFS for 3L+: time from randomization to progression per RECIST 1.1 assessed by BICR or death. ORR: proportion with confirmed CR or PR per BICR using RECIST 1.1. DoR: time from first documented confirmed response to documented progression per RECIST 1.1 by BICR or death. PK endpoints: serum concentrations and PK parameter assessment. Immunogenicity: presence of anti-drug antibodies (ADAs) assessed in serum. Safety: incidence of adverse events (AEs) and serious adverse events (SAEs)."}

Recruitment

Planned Sample Size
472
Recruitment Window Months
22
Consent Approach
Informed consent must be provided by the participant (participants must be ≥18 years). Subject information and ICF documents and addenda are provided for adult participants and pregnant partners; country/language versions are present (examples in the record include PL, FR, ES, IT, EN). Specific assent procedures are not provided in the available data.

Geography

Total Number Of Sites
44
Total Number Of Participants
91

Germany

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
619
Number Of Sites
14
Number Of Participants
30

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie II. Medizinische Klinik und Poliklinik
Contact Person Name
Marianne Sinn
Contact Person Email
ma.sinn@uke.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
Contact Person Name
Annika Kurreck
Contact Person Email
annika.kurreck@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Contact Person Name
Markus Moehler
Site Name
Vivantes MVZ GmbH
Department Name
Haematologie, Onkologie und Palliativmedizin
Contact Person Name
Peter Thuss Patience
Contact Person Email
Peter.Thuss@vivantes.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Klinik fuer Innere Medizin III
Contact Person Name
Uwe Martens
Contact Person Email
medklinik3@slk-kliniken.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen NCT
Contact Person Name
Georg Martin Haag
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Internistische Onkologie und Onkologische Palliativmedizin
Contact Person Name
Christian Mueller
Contact Person Email
ch.mueller@kem-med.com
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik 3
Contact Person Name
Kathrin Heinrich
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik I Internistische Onkologie
Contact Person Name
Gunnar Folprecht
Site Name
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name
Klinik für Gastroenterologie und Onkologie
Contact Person Name
Mischa Franz Moeller
Site Name
Krankenhaus Nordwest GmbH
Department Name
Klinisch-Onkologische Forschung
Contact Person Name
Thorsten Oliver Goetze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Philipps-Universitaet Marburg
Department Name
Klinik fuer Innere Medizin - Schwerpunkt Haematologie, Onkologie und Immunologie
Contact Person Name
Jorge Riera Knorrenschild
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Gastroenterologie und gastrointestinale Onkologie
Contact Person Name
Alexander Koenig
Site Name
Universitaet Leipzig
Department Name
Universitaeres Krebszentrum Leipzig
Contact Person Name
Gertraud Stocker

Poland

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
413
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Oddzial Onkologii i Chemioterapii Kliniki Chrurgii Onkologicznej
Contact Person Name
Tomasz Ciszewski
Contact Person Email
tciszewski@usk1.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej / Chemioterapii
Contact Person Name
Joanna Wojcik-Tomaszewska
Contact Person Email
jwojcik@wco.gda.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddzial Onkologii Klinicznej
Contact Person Name
Michal Kliber
Contact Person Email
mkliber@uck.katowice.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej, Chemioterapii, Badan Klinicznych
Contact Person Name
Wojciech Rogowski
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii
Contact Person Name
Wojciech Solarek
Contact Person Email
wsolarek@wim.mil.pl
Site Name
Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej SPZOZ
Department Name
Katedra i Klinika Onkologii
Contact Person Name
Rafal Wisniowski
Contact Person Email
wiraf@poczta.onet.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@nio.gov.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddzial Kliniczny Onkologii/Poradnia Onkologiczna
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@edu.uj.pl

France

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
648
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Hopital Prive Jean Mermoz
Department Name
Digestive Oncology
Contact Person Name
Pascal Artru
Contact Person Email
dr.artru@wanadoo.fr
Site Name
Hopital Saint Antoine
Department Name
Medical Oncology
Contact Person Name
Romain Cohen
Contact Person Email
romain.cohen@aphp.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Medical Oncology
Contact Person Name
Jean-Philippe Metges
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Digestive Oncology
Contact Person Name
Juliette Boilève
Contact Person Email
juliette.boileve@chu-nantes.fr
Site Name
Besancon University Hospital Center
Department Name
Medical Oncology
Contact Person Name
Christophe Borg
Contact Person Email
christophe.borg@efs.sante.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Digestive Oncology
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Oncology
Contact Person Name
Anthony Turpin
Contact Person Email
anthony.turpin@chu-lille.fr

Italy

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
664
Number Of Sites
8
Number Of Participants
19

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology
Contact Person Name
Filippo Pietrantonio
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Hospital Department of Oncology and Hematology
Contact Person Name
Andrea Spallanzani
Contact Person Email
spallanzani.andrea@aou.mo.it
Site Name
Careggi University Hospital
Department Name
SODc Oncologia Clinica
Contact Person Name
Lorenzo Antonuzzo
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2 Universitaria
Contact Person Name
Lorenzo Fornaro
Contact Person Email
lorenzo.fornaro@gmail.com
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Medical Oncology
Contact Person Name
Katia Bruna Bencardino
Site Name
Istituto Oncologico Veneto
Department Name
Oncology 1
Contact Person Name
Sabina Murgioni
Contact Person Email
sabina.murgioni@iov.veneto.it
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
Medical Oncology
Contact Person Name
Alessandro Cappetta
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Precision Medicine
Contact Person Name
Ferdinando De Vita

Spain

Earliest CTIS Part Ii Submission Date
06-03-2025
Latest Decision Or Authorization Date
08-08-2025
Processing Time Days
155
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Servicio de Oncologia
Contact Person Name
Fernando Rivera Herrero
Contact Person Email
fernando.rivera@scsalud.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Oncologia
Contact Person Name
Maria Luisa Limon Miron
Contact Person Email
mllimon02@hotmail.com
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Servicio de Oncologia
Contact Person Name
Ana Fernandez Montes
Contact Person Email
ana.fernandez.montes@sergas.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncologia
Contact Person Name
Maria del Carmen Riesco Martinez
Contact Person Email
m.carmen.riesco@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Oncologia
Contact Person Name
Federico Mongo Munoz
Contact Person Email
fedelongomunoz@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncologia
Contact Person Name
Daniel Alejandro Acosta Eyzaguirre
Contact Person Email
dacosta@vhio.net
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Oncologia
Contact Person Name
Tamara Sauri Nadal
Contact Person Email
sauri@clinic.cat

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
AZD0901
Active Substance
AZD0901
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Investigational Product Name
Lonsurf 15 mg/6.14 mg film-coated tablets
Active Substance
Trifluridine, Tipiracil hydrochloride
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Investigational Product Name
Lonsurf 20 mg/8.19 mg film-coated tablets
Active Substance
Trifluridine, Tipiracil
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Investigational Product Name
Cyramza 10 mg/ml concentrate for solution for infusion
Active Substance
Ramucirumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Paclitaxel Bendalis 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
Paclitaxel
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Docetaxel Hikma 80 mg/4 ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
Docetaxel
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Irinotecan Bendalis 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
Irinotecan hydrochloride trihydrate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Investigational Product Name
Irinotecan Accord, 20 mg/ml, koncentrat do sporządzania roztworu do infuzji
Active Substance
Irinotecan hydrochloride trihydrate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS

Related trials

Other published trials that may interest you.