Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
150
Countries
2
Sites
18
Locally Advanced Resectable Gastroesophageal Adenocarcinoma
To assess the safety and tolerability of perioperative treatment. To assess the anti-tumor activity of neoadjuvant treatment in terms of pathological response.
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others, Pharmacokinetic, Safety
To assess the safety and tolerability of perioperative treatment.
To assess the anti-tumor activity of neoadjuvant treatment in terms of pathological response.
Conditions and MedDRA coding
Locally Advanced Resectable Gastroesophageal Adenocarcinoma
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Pre-screening period (optional) Up to 28 days prior to mail screening. Upon signing a pre-screening ICF, participants may be assessed for local available biomarker status.
|
2 | None | ||
| 2 | Main Screening period Day - 28 to Day -1. Participants will be assessed for study treatment eligibility. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be able to start protocol-assigned study treatment in one sub-study.
|
2 | None | ||
| 3 | Treatment period Eligible participants will receive corresponding treatment of novel agents or novel combinations. Neoadjuvant treatment will be administered beginning on Day 1 of Cycle 1.
|
2 | None | ||
| 4 | Follow-up period All participants will undergo an EOT visit (22 to 30 days after the last dose of the study intervention, which includes surgery) and will have post-treatment follow-up for up to 12 months since the last dose of the study intervention and a survival follow-up thereafter every 6 months until death, withdrawal of consent, or lost to follow-up.
|
2 | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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.
- Master and Sub 1-3: 2. Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease.
- Master and Sub 1-3: 3. Participants who are CLDN18.2 positive and HER2 negative in Substudy 1 or HER2 positive in Substudy 2.
- Master and Sub 1-3: 4. ECOG 0 or 1.
- Master and Sub 1-3: 5. Adequate organ and bone marrow function.
- Master and Sub 1-3: 6. Body weight > 35 kg.
Exclusion criteria 9
- Master and Sub 1-3: 1. Participants had any prior anti-cancer treatment for the current gastric, GEJ, or esophageal cancer.
- Master and Sub 1-3: 2. Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
- Master and Sub 1-3: 3. CNS pathology.
- Master and Sub 1-3: 4. Uncontrolled infection.
- Master and Sub 1-3: 5. Participants with history of (non-infectious) ILD/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis.
- Master and Sub 1-3: 6. History of another primary malignancy.
- Master and Sub 1-3: 7. Participants with any known or suspicious distant metastasis.
- Only for Sub-study 1: 8. Uncontrolled hepatitis B and/or chronic or active hepatitis B.
- 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 and secondary outcome measures (English text)
Primary endpoints 2
- -The measures of interest include the incidence of AEs and SAEs, and descriptive statistics summarizing laboratory findings, vital signs, and ECGs.
- -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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD5308994 · Product
- Active substance
- Trastuzumab Deruxtecan
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 00 mg/Kg milligram(s)/kilogram
- Max total dose
- 00 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- DAIICHI SANKYO, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10448215 · Product
- Active substance
- Rilvegostomig
- Substance synonyms
- AZD 2936, Bispecific IgG1 monoclonal antibody against PDCD1 and TIGIT
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 00 mg/Kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10993091 · Product
- Active substance
- AZD0901
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 00 mg/Kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Centre
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Centre
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 13, Other, Code 2, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, E-data capture, Code 8, Code 9 |
Locations
2 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 8 | 9 |
| Spain | Ongoing, recruitment ended | 9 | 9 |
| Rest of world
Japan, United States, Turkey, Canada, United Kingdom, Georgia, Taiwan, China
|
— | 133 | — |
Investigational sites
Azienda Unita Locale Socio Sanitaria N 8 Berica
4106; Oncologia Medica, Viale Ferdinando Rodolfi 37, 36100, Vicenza
Azienda Sanitaria Universitaria Friuli Centrale
4108; Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Fondazione IRCCS Istituto Nazionale Dei Tumori
4107; S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero Universitaria Pisana
4105; UO Oncologia Medica 2 - Oncology, Via Roma 67, 56126, Pisa
Istituto Europeo Di Oncologia S.r.l.
4101;Oncologia medica gastrointestinale, Via Giuseppe Ripamonti 435, 20141, Milan
Humanitas Mirasole S.p.A.
4103;Unità Opeativa Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero Universitaria Careggi
4104;SODc Oncologia Medica e Clinica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero Universitaria Di Modena
4109; SC di Oncologia, Largo Del Pozzo 71, 41124, Modena
ASST Grande Ospedale Metropolitano Niguarda
4102; Hematology and Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Hospital Clinico Universitario De Valencia
7007; Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Central De Asturias
7008; Oncology, Avenida De Roma S/n, 33011, Oviedo
Complejo Hospitalario Universitario De Ourense
7003; Oncology, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital General Universitario De Elche
7004; Oncology, Edificio 2, Camino De La Almazara 11, Elche
Hospital General Universitario Gregorio Maranon
7001; Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Marques De Valdecilla
7005; Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Regional De Malaga
7009; Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Clinic De Barcelona
7006; Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
7002; Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2025-12-11 | 2026-02-05 | 2026-04-30 | ||
| Spain | 2025-10-28 | 2025-10-29 | 2026-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Main English D9804C00001 Public | 2.0 |
| Protocol (for publication) | D1_Protocol Substudy 1 English D9804C00001 Public | 2.0 |
| Protocol (for publication) | D1_Protocol Substudy 2 English D9804C00001 Public | 2.0 |
| Protocol (for publication) | D1_Protocol Substudy 3 English D9804C00001 Public | 2.0 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Procedure Description English D9804C00001 Public | 2 |
| Recruitment arrangements (for publication) | K1_ITA Country ICF Procedure Adult English D9804C00001 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Genetic Research Spanish D9804C00001 Public | 1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish D9804C00001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Other Pregnant Partner Spanish D9804C00001 Public | 1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Research Spanish D9804C00001 Public | 1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Screening Spanish D9804C00001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Data Protection Italian D9804C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Genetic Research Italian D9804C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Italian D9804C00001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Pregnancy Italian D9804C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Glossary Italian D9804C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Opt FR Italian D9804C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Screening Italian D9804C00001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_ESP Subject Materials Other ILD Patient Guide Spanish D9804C00001 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main English D9804C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Italian D9804C00001 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Spanish D9804C00001 Public | 1.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-09 | Italy | Acceptable with conditions 2025-09-01
|
2025-09-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-06 | Italy | Acceptable 2025-12-15
|
2025-12-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-10 | Italy | Acceptable 2026-04-28
|
2026-04-29 |