Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
341
Countries
1
Sites
6
Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
To assess the efficacy of novel agent plus chemotherapy by evaluation of ORR (objective response rate) and PFS6 (proportion of participants alive and progression-free at 6 months)
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
- 14 Apr 2023 → ongoing
- Decision date (initial)
- 2024-04-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2024-510977-27-00
- EudraCT number
- 2022-002840-29
- ClinicalTrials.gov
- NCT05702229
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Safety, Therapy, Dose response, Efficacy
To assess the efficacy of novel agent plus chemotherapy by evaluation of ORR (objective response rate) and PFS6 (proportion of participants alive and progression-free at 6 months)
Secondary objectives 1
- To evaluate the DoR (Duration of response), PFS (progression free survival), OS (overall survival), safety and tolerability, PK and immunogenicity of novel agent plus chemotherapy
Conditions and MedDRA coding
Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10001150 | Adenocarcinoma gastric | 100000004864 |
| 21.1 | LLT | 10066354 | Adenocarcinoma of the gastroesophageal junction | 10029104 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Substudy 1 Volrustomig plus XELOX (capecitabine and oxaliplatin) or FOLFOX (5-fluorouracil, oxaliplatin, and leucovorin).
|
Not Applicable | None | Substudy 1: Objectives: Please refer to the E.2.1 Main objective of the trial and E.2.2 secondary objectives of the trial. | |
| 2 | Substudy 2 Rilvegostomig plus XELOX or FOLFOX
|
Not Applicable | None | Substudy 2: Objectives: Please refer to the E.2.1 Main objective of the trial and E.2.2 secondary objectives of the trial. | |
| 3 | Substudy 3 Sonesitatug vedotin (AZD0901) plus volrustomig and 5-fluorouracil or capecitabine.
|
Not Applicable | None | Substudy 3: Objectives: Please refer to the E.2.1 Main objective of the trial and E.2.2 secondary objectives of the trial. | |
| 4 | Substudy 4 Cohort 4a1, Cohort 4a2, Cohort 4b
Objectives: Please refer to the E.2.1 Main objective of the trial and E.2.2 secondary objectives of the trial.
|
Not Applicable | None | Cohort 4a1: Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine. Cohort 4a2: Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil. Cohort 4b: Sonesitatug vedotin (AZD0901) plus capecitabine. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 18 years or older at the time of signing the ICF.
- Body weight > 35 kg.
- Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Has measurable target disease assessed by the Investigator based on RECIST 1.1.
- ECOG PS 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate organ and bone marrow function.
- Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 is open for recruitment
Exclusion criteria 8
- Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by ISH) or indeterminate gastric or GEJ carcinoma.
- Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
- Participants with ascites which cannot be controlled with appropriate interventions.
- Uncontrolled intercurrent illness.
- Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
- History of another primary malignancy.
- Previous treatment with an immune-oncology agent.
- Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- ORR in response evaluable set
- PFS6 in full analysis set
Secondary endpoints 6
- DoR per RECIST 1.1 based on Investigator assessment.
- PFS per RECIST 1.1 as assessed by the Investigator.
- OS.
- Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG.
- Incidences of ADAs against novel agent in serum.
- Serum concentrations of novel agent and derived PK parameters.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
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
- INTRAVENOUS USE
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999999 Month(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
- INTRAVENOUS USE
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10191166 · Product
- Active substance
- Volrustomig
- Substance synonyms
- MEDI5752, Human IgG1 monoclonal antibody with an engineered Fc domain targeting PD-1 and CTLA-4
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10715225 · Product
- Active substance
- Sabestomig
- Substance synonyms
- AZD7789, Bispecific IgG1 kappa/lambda monoclonal antibody against PD-1 and TIM-3
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 5
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 85 mg/m2 milligram(s)/square meter
- Max total dose
- 85 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06052MIG · Substance
- Active substance
- Calcium Folinate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 400 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg/m2 milligram(s)/square meter
- Max total dose
- 2000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg/m2 milligram(s)/square meter
- Max total dose
- 2000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 400 mg/m2 milligram(s)/square meter
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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 Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 8 | 6 |
| Rest of world
Taiwan, China, Japan, United Kingdom, Korea, Democratic People's Republic of, United States
|
— | 333 | — |
Investigational sites
Hospital General Universitario De Elche
Oncología Médica, Edificio 2, Camino De La Almazara 11, Elche
Hospital Universitari Vall D Hebron
Oncología Médica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Maranon
Oncología Médica, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Clinico San Carlos
Oncología Médica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Institut Catala D'oncologia
Oncología Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Marques De Valdecilla
Oncología Médica, Avenida Valdecilla Sn, 39008, Santander
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 |
|---|---|---|---|---|---|
| Spain | 2023-04-14 | 2023-04-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Synopsis-lay-summary_redacted | 2.0 |
| Protocol (for publication) | D1_Protocol_2024-510977-27-00_redacted | 5.0 ESP |
| Protocol (for publication) | D1_Protocol_2024-510977-27-00_substudy1_redacted | 5.0 ESP |
| Protocol (for publication) | D1_Protocol_2024-510977-27-00_substudy2_redacted | 5.0 ESP |
| Protocol (for publication) | D1_Protocol_2024-510977-27-00_substudy3_redacted | 5.0 ESP |
| Protocol (for publication) | D1_Protocol_2024-510977-27-00_substudy4_redacted | 5.0 ESP |
| Protocol (for publication) | D1_Protocol_2024-510977-27-00_substudy5_redacted | 4.0 |
| Protocol (for publication) | D1_Protocol_2024-510977-27-00_substudy6_redacted | 4.0 |
| Protocol (for publication) | D1_tmg_AZD0901 | 4.0 |
| Protocol (for publication) | D1_tmg_AZD7789 | 6.0 |
| Protocol (for publication) | D1_tmg_Volrustomig_redacted | 5.0 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | NA |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Genetic | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partners | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Retreatment | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_Lay language 2024-510977-27-00_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_redacted | 1.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-25 | Spain | Acceptable 2024-04-01
|
2024-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-21 | Spain | Acceptable 2024-08-02
|
2024-08-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-06 | Spain | Acceptable 2024-11-21
|
2024-11-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-13 | Spain | Acceptable 2025-01-30
|
2025-02-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-26 | Spain | Acceptable 2025-05-09
|
2025-05-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-13 | Spain | Acceptable 2025-07-28
|
2025-07-31 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-05 | Spain | Acceptable 2025-10-20
|
2025-10-23 |
| 8 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-01-30 | Spain | Acceptable 2026-04-20
|
2026-04-24 |