Clinical trial • Phase II • Oncology

AZD0901 for Gastroesophageal adenocarcinoma

Phase II trial of AZD0901 for Gastroesophageal adenocarcinoma. open-label, none/not specified-controlled. 133 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastroesophageal adenocarcinoma
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme|Bispecific antibody|ADC

Key dates

Initial CTIS Submission Date
09-05-2025
First CTIS Authorization Date
01-09-2025

Trial design

open-label, none/not specified-controlled Phase II trial in Italy, Spain.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True - CLDN18.2 positive and HER2 status (Substudy 1: CLDN18.2 positive and HER2 negative; Substudy 2: HER2 positive)
Target Sample Size
133

Eligibility

Recruits 133 Vulnerable population is selected in the trial record. Informed consent is required from adult participants (participants must be at least 18 years old). Country-specific subject information and informed consent forms are listed for Italy and Spain (ICFs available in Italian and Spanish; recruitment/procedure documents in English also listed). No explicit assent process for minors is provided (minimum age is 18)..

Vulnerable Population
Vulnerable population is selected in the trial record. Informed consent is required from adult participants (participants must be at least 18 years old). Country-specific subject information and informed consent forms are listed for Italy and Spain (ICFs available in Italian and Spanish; recruitment/procedure documents in English also listed). No explicit assent process for minors is provided (minimum age is 18).

Inclusion criteria

  • {"criterion_text":"-Master and Sub 1-3: 1.Participants must be at least 18 or less than 75 years of age at the time of signing the ICF.\n-Master and Sub 1-3: 2. Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease.\n-Master and Sub 1-3: 3. Participants who are CLDN18.2 positive and HER2 negative in Substudy 1 or HER2 positive in Substudy 2.\n-Master and Sub 1-3: 4. ECOG 0 or 1.\n-Master and Sub 1-3: 5. Adequate organ and bone marrow function.\n-Master and Sub 1-3: 6. Body weight > 35 kg."}

Exclusion criteria

  • {"criterion_text":"-Master and Sub 1-3: 1. Participants had any prior anti-cancer treatment for the current gastric, GEJ, or esophageal cancer.\n-Master and Sub 1-3: 2. Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.\n-Master and Sub 1-3: 3. CNS pathology.\n-Master and Sub 1-3: 4. Uncontrolled infection.\n-Master and Sub 1-3: 5. Participants with history of (non-infectious) ILD/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis.\n-Master and Sub 1-3: 6. History of another primary malignancy.\n-Master and Sub 1-3: 7. Participants with any known or suspicious distant metastasis.\n-Only for Sub-study 1: 8. Uncontrolled hepatitis B and/or chronic or active hepatitis B.\n-Master and Sub 1-3: Prior/Concomitant Therapy:9. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The measures of interest include the incidence of AEs and SAEs, and descriptive statistics summarizing laboratory findings, vital signs, and ECGs.","definition_or_measurement_approach":"Incidence of adverse events (AEs) and serious adverse events (SAEs) will be measured; laboratory findings, vital signs and ECGs will be summarized using descriptive statistics."}
  • {"endpoint_text":"-The analysis will include participants in mITT. -The measure of interest is the pCR rate, which is the proportion of participants with 0% residual viable tumor cells within all resected tissue.","definition_or_measurement_approach":"Analysis population: modified intent-to-treat (mITT). pCR (pathological complete response) rate defined as the proportion of participants with 0% residual viable tumor cells within all resected tissue."}

Recruitment

Planned Sample Size
133
Recruitment Window Months
40
Consent Approach
Informed consent is obtained from adult participants (minimum age 18). Country-specific subject information and informed consent forms are provided (documents listed for Italy and Spain: L1_ITA and L1_ESP country ICFs). Recruitment procedure description documents available (K1 documents) and some materials in English; participants must sign the ICF.

Geography

Total Number Of Sites
21
Total Number Of Participants
17

Italy

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
272
Number Of Sites
10
Number Of Participants
8

Sites

Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
4106; Oncologia Medica
Principal Investigator Name
Alessandro Cappetta
Principal Investigator Email
alessandro.cappetta@aulss8.veneto.it
Contact Person Name
Alessandro Cappetta
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
4102; Hematology and Oncology
Principal Investigator Name
Katia Bencardino
Principal Investigator Email
katiabruna.bencardino@ospedaleniguarda.it
Contact Person Name
Katia Bencardino
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
4108; Oncologia
Principal Investigator Name
Giuseppe Aprile
Principal Investigator Email
giuseppe.aprile@aulss8.veneto.it
Contact Person Name
Giuseppe Aprile
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
4101;Oncologia medica gastrointestinale
Principal Investigator Name
Chiara Cella
Principal Investigator Email
chiaraalessandra.cella@ieo.it
Contact Person Name
Chiara Cella
Contact Person Email
chiaraalessandra.cella@ieo.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
4105; UO Oncologia Medica 2 - Oncology
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
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
4107; S.C. Oncologia Medica 1
Principal Investigator Name
Filippo Pietrantonio
Principal Investigator Email
filippo.pietrantonio@istitutotumori.mi.it
Contact Person Name
Filippo Pietrantonio
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
4104;SODc Oncologia Medica e Clinica
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
lorenzo.antonuzzo@unifi.it
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@unifi.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
4109; SC di Oncologia
Principal Investigator Name
Andrea Spallanzani
Principal Investigator Email
andrea.spallanzani@gmail.com
Contact Person Name
Andrea Spallanzani
Contact Person Email
andrea.spallanzani@gmail.com
Site Name
Humanitas Mirasole S.p.A.
Department Name
4103;Unità Opeativa Oncologia Medica ed Ematologia
Principal Investigator Name
Armando Santoro
Principal Investigator Email
trials.santoro@cancercenter.humanitas.it
Contact Person Name
Armando Santoro
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica (additional listed site entries consolidated)

Spain

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
286
Number Of Sites
11
Number Of Participants
9

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
7007; 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 General Universitario De Elche
Department Name
7004; Oncology
Principal Investigator Name
Javier Gallego Plazas
Principal Investigator Email
j.gallegoplazas@gmail.com
Contact Person Name
Javier Gallego Plazas
Contact Person Email
j.gallegoplazas@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
7009; Oncology
Principal Investigator Name
Inmaculada Alés Diaz
Principal Investigator Email
inmaculadac.ales.sspa@juntadeandalucia.es
Contact Person Name
Inmaculada Alés Diaz
Site Name
Hospital Clinic De Barcelona
Department Name
7006; Oncology
Principal Investigator Name
Tamara Sauri Nadal
Principal Investigator Email
sauri@clinic.cat
Contact Person Name
Tamara Sauri Nadal
Contact Person Email
sauri@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
7005; Oncology
Principal Investigator Name
Fernando Rivera Herrero
Principal Investigator Email
fernando.rivera@scsalud.es
Contact Person Name
Fernando Rivera Herrero
Contact Person Email
fernando.rivera@scsalud.es
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
7003; Oncology
Principal Investigator Name
Ana Fernández Montes
Principal Investigator Email
ana.fernandez.montes@sergas.es
Contact Person Name
Ana Fernández Montes
Contact Person Email
ana.fernandez.montes@sergas.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
7002; Oncology
Principal Investigator Name
Daniel Alejandro Acosta Eyzaguirre
Principal Investigator Email
dacosta@vhio.net
Contact Person Name
Daniel Alejandro Acosta Eyzaguirre
Contact Person Email
dacosta@vhio.net
Site Name
Hospital Universitario Central De Asturias
Department Name
7008; Oncology
Principal Investigator Name
Paula Jiménez Fonseca
Principal Investigator Email
palucaji@hotmail.com
Contact Person Name
Paula Jiménez Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
7001; Oncology
Principal Investigator Name
Aitana Calvo Ferrándiz
Principal Investigator Email
pilaraitana.calvo@salud.madrid.org
Contact Person Name
Aitana Calvo Ferrándiz
Site Name
Hospital Universitario Central De Asturias (additional listed site entries consolidated)
Site Name
Hospital Universitario Central De Asturias (additional listed site entries consolidated)

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Multiple sponsor duties indicated (codes 1,2,3,4,5,6,7,8,9,10,11,12,13,15), including 'Logistic management'; contact Clinicaltrial.Enquiries@parexel.com

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes present: 1,10,11,12,13,15 (Logistic management),2,3,4,5,6,7,8,9; contact Clinicaltrial.Enquiries@parexel.com; logistic management noted.","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
AZD0901
Active Substance
AZD0901
Modality
Peptide/protein/enzyme
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (prodAuthStatus=1)
Investigational Product Name
Rilvegostomig
Active Substance
RILVEGOSTOMIG
Modality
Bispecific antibody
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (prodAuthStatus=1)
Investigational Product Name
DS-8201a
Active Substance
Trastuzumab deruxtecan
Modality
ADC
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (prodAuthStatus=1)
Combination Treatment
Yes

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