Gastric CancerPhase 1/2NCT06005493
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing AZD5863 and AZD2936 in people with Gastric Cancer and Gastro-esophageal Junction Cancer, run by AstraZeneca at 25 sites in 8 countries.
Trial summary
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- AZD5863 and AZD2936
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 25 sitesin 8 countries
- Study dates
- 11 Jul 2023to 16 Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 at the time of signing the informed consent
- Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
- Predicted life expectancy of ≥ 12 weeks
Show all 9Show fewer
- Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol
- Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol
- Must have received at least one prior line of systemic therapy in the advanced/metastatic setting
Who cannot join
- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
- Participant experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
- central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
- Infectious disease including active human immunodeficiency virus (HIV), active hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection
Show all 11Show fewer
- Cardiac conditions as defined by the protocol
- History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
- Participant requires chronic immunosuppressive therapy
- Participants on anticoagulation therapy with long-acting anticoagulants or other class of anticoagulants at therapeutic doses Module 3 - Active or ongoing interstitial lung disease / pneumonitis, serious chronic gastrointestinal conditions Module 3 - Any of the following cardiac conditions as determined by investigator: Complex ventricular arrhythmia, symptomatic heart failure, Cardiomyopathy, myocardial infarction or unstable angina (within past 6 months) and uncontrolled hypertension.
- Module 3 - Known allergy or hypersensitivity to rilvegostomig or its excipients Module 3 - Prior exposure to an anti-TIGIT therapy
Trial locations and contacts
25 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
25 sites in 8 countries
South Korea4 sites, 4 recruiting
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 05505
- Recruiting
Research Site
Seoul, 06351
United Kingdom4 sites, 4 recruiting
- Recruiting
Research Site
Dundee, DD1 9SY
- Recruiting
Research Site
London, E1 1BB
- Recruiting
Research Site
Metropolitan Borough of Wirral, CH63 4JY
- Recruiting
Research Site
Oxford, OX3 7LE
United States3 sites, 2 recruiting
- Recruiting
Research Site
Jacksonville, Florida, 32224
- Withdrawn
Research Site
New York, New York, 10065
- Recruiting
Research Site
Rochester, Minnesota, 55905
China3 sites, 3 recruiting
- Recruiting
Research Site
Beijing, 100142
- Recruiting
Research Site
Beijing, 101199
- Recruiting
Research Site
Shandong
Japan3 sites, 3 recruiting
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Kashiwa, 227-8577
- Recruiting
Research Site
Kōtoku, 135-8550
Netherlands3 sites, 3 recruiting
- Recruiting
Research Site
Amsterdam, 1081 HV
- Recruiting
Research Site
Groningen, 9713 GZ
- Recruiting
Research Site
Rotterdam, 3015 GD
Taiwan3 sites, 3 recruiting
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
Tainan, 70403
- Recruiting
Research Site
Taoyuan, 00333
France2 sites, 2 recruiting
- Recruiting
Research Site
Toulouse, 31059
- Recruiting
Research Site
Villejuif, 94805
About this study
Official title: A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.
Read the detailed description
This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumors, or AZD5863 in combination with Rilvegostomig (Module 3). Each module contains dose-escalation (Part A) and dose-expansion (Part B).
- Conditions
- Gastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma
- Being tested
- AZD5863, AZD2936
- Keywords
- CLDN18.2 / Claudin 18.2, CD3, T cell-engaging bi-specific antibody, Gastric cancer, Gastro-esophageal junction cancer, Pancreatic ductal adenocarcinoma, Solid tumors, AZD5863
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5863Drug
T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells
AZD2936Drug
Also called Rilvegostomig
Rilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways.
| Study group | Role | What they receive |
|---|---|---|
| Module 1: AZD5863 Monotherapy Intravenous (IV) | Experimental | Module 1: AZD5863 Intravenous (IV) Monotherapy Receives: Drug: AZD5863 |
| Module 2: AZD5863 Monotherapy Subcutaneous (SC) | Experimental | Module 2: AZD5863 Subcutaneous (SC) Monotherapy Receives: Drug: AZD5863 |
| Module 3: AZD5863 Combination and Rilvegostomig | Experimental | Module 3: AZD5863 Combination and Rilvegostomig Receives: Drug: AZD5863; Drug: AZD2936 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with adverse events
Number of patients with adverse events by system organ class and preferred term
Measured: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
The number of patients with adverse events of special interest
Number of patients with adverse events of special interest by system organ class and preferred term
Measured: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.
Measured: From first dose of study drug until the end of Cycle 1
The number of patients with serious adverse events
Number of patients with serious adverse events by system organ class and preferred term
Measured: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Objective Response Rate (ORR)
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose expansion only.
Measured: From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
Secondary outcomes (11)
Objective Response Rate (ORR)
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose escalation only.
Measured: From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
Disease Control Rate (DCR)
Percentage of patients with confirmed complete or partial response or having stable disease maintained for >= 11 weeks from first dose, according to response criteria in solid tumours (RECIST 1.1).
Measured: From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
Duration of response (DoR)
The time from the date of first response until date of disease progression or death in the absence of disease progression, according to response criteria in solid tumours (RECIST 1.1).
Measured: From the first documented response to progressive disease or death in the absence of disease progression (approx. 2 years)
Progression free Survival (PFS)
The time from the start of study treatment/date of randomization until RECIST 1.1 defined disease progression or death in the absence of disease progression.
Measured: From the start of study treatment/date of randomization to progressive disease or death in the absence of disease progression (approx. 2 years)
Overall Survival (OS)
The time from the start of study treatment/date of randomization until death due to any cause.
Measured: From the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)
Pharmacokinetics of AZD5863: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of the study drug
Measured: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Pharmacokinetics of AZD5863: Area Under the concentration-time curve (AUC)
Area under the plasma concentration-time curve
Measured: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Pharmacokinetics of AZD5863: Clearance
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.
Measured: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Pharmacokinetics of AZD5863: Terminal elimination half-life (t 1/2)
Terminal elimination half life.
Measured: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Immunogenicity of AZD5863
The number and percentage of participants who develop anti-drug antibodies (ADAs) measured in serum
Measured: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Preliminary antitumor activity with target expression pre- and post-delivery of AZD5863
Measure CLDN18.2 expression (IHC) in baseline and/or on-treatment tumor biopsies and correlate with clinical outcome
Measured: From time of Informed consent, at predefined intervals (including screening, on-treatment or end of treatment) throughout the study (over approx. 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start11 Jul 2023
- Primary completion16 Mar 2029 (estimated)
- Study completion16 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study consists of individual modules each evaluating the safety and tolerability of AZD5863 dosed as monotherapy: * Module 1: AZD5863 intravenous administration * Module 2: AZD5863 subcutaneous administration * Module 3: AZD5863 + Rilvegostomig administration Modules 1, 2 and 3 each consist of two parts: Part A, Dose Escalation and Part B, Dose Expansion.
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005493
- Sponsor's protocol ID
- D9750C00001
- Other IDs
- 2023-504139-42-00, 2023-000154-20, 2023
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Gaspar M, Natoli M, Castan L, Rahmy S, Korade M 3rd, Kelton C, Mulgrew K, Huhn O, Rees DG, Sigurdardottir A, Lloyd C, Taylor JJ, Brailey PM, Dallaway L, Toloczko A, Giraldo N, Broggi MAS, Kunihiro A, Abhishek S, He Y, Rong Y, Eyles J, Ball K, Fitzgerald J, Hammond SA, Cemerski S, Dovedi SJ, Cobbold M. An affinity-modulated T cell engager targeting Claudin 18.2 shows potent anti-tumor activity with limited cytokine release. J Immunother Cancer. 2025 Aug 4;13(8):e011857. doi: 10.1136/jitc-2025-011857.
PubMed 40759445
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06005493
- Acronym / sponsor ID
- D9750C00001
- Conditions
- Gastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma
- Keywords
- CLDN18.2 / Claudin 18.2, CD3, T cell-engaging bi-specific antibody, Gastric cancer, Gastro-esophageal junction cancer, Pancreatic ductal adenocarcinoma, Solid tumors, AZD5863
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 16 Mar 2029 (estimated)
- Study completion
- 16 Mar 2029 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.
Detailed description
This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumors, or AZD5863 in combination with Rilvegostomig (Module 3). Each module contains dose-escalation (Part A) and dose-expansion (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study consists of individual modules each evaluating the safety and tolerability of AZD5863 dosed as monotherapy: * Module 1: AZD5863 intravenous administration * Module 2: AZD5863 subcutaneous administration * Module 3: AZD5863 + Rilvegostomig administration Modules 1, 2 and 3 each consist of two parts: Part A, Dose Escalation and Part B, Dose Expansion.
| Arm | Type | Receives |
|---|---|---|
| Module 1: AZD5863 Monotherapy Intravenous (IV) | Experimental | Drug: AZD5863Module 1: AZD5863 Intravenous (IV) Monotherapy |
| Module 2: AZD5863 Monotherapy Subcutaneous (SC) | Experimental | Drug: AZD5863Module 2: AZD5863 Subcutaneous (SC) Monotherapy |
| Module 3: AZD5863 Combination and Rilvegostomig | Experimental | Drug: AZD5863, Drug: AZD2936Module 3: AZD5863 Combination and Rilvegostomig |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 at the time of signing the informed consent
- Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
Key exclusion criteria (11 listed)
- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
- Participant experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
- central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5863T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells | Drug | Module 1: AZD5863 Monotherapy Intravenous (IV), Module 2: AZD5863 Monotherapy Subcutaneous (SC), Module 3: AZD5863 Combination and Rilvegostomig |
| AZD2936Also: RilvegostomigRilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways. | Drug | Module 3: AZD5863 Combination and Rilvegostomig |
Primary outcome
The number of patients with adverse events
Time frame: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with adverse events by system organ class and preferred term
The number of patients with adverse events of special interest
Time frame: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with adverse events of special interest by system organ class and preferred term
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
Time frame: From first dose of study drug until the end of Cycle 1
A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.
The number of patients with serious adverse events
Time frame: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Number of patients with serious adverse events by system organ class and preferred term
Objective Response Rate (ORR)
Time frame: From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose expansion only.
11 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
Disease Control Rate (DCR)
Time frame: From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
Duration of response (DoR)
Time frame: From the first documented response to progressive disease or death in the absence of disease progression (approx. 2 years)
Progression free Survival (PFS)
Time frame: From the start of study treatment/date of randomization to progressive disease or death in the absence of disease progression (approx. 2 years)
Overall Survival (OS)
Time frame: From the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)
Pharmacokinetics of AZD5863: Maximum plasma concentration of the study drug (Cmax)
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Pharmacokinetics of AZD5863: Area Under the concentration-time curve (AUC)
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Pharmacokinetics of AZD5863: Clearance
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Pharmacokinetics of AZD5863: Terminal elimination half-life (t 1/2)
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Immunogenicity of AZD5863
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Preliminary antitumor activity with target expression pre- and post-delivery of AZD5863
Time frame: From time of Informed consent, at predefined intervals (including screening, on-treatment or end of treatment) throughout the study (over approx. 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 40759445Gaspar M, Natoli M, Castan L, Rahmy S, Korade M 3rd, Kelton C, Mulgrew K, Huhn O, Rees DG, Sigurdardottir A, Lloyd C, Taylor JJ, Brailey PM, Dallaway L, Toloczko A, Giraldo N, Broggi MAS, Kunihiro A, Abhishek S, He Y, Rong Y, Eyles J, Ball K, Fitzgerald J, Hammond SA, Cemerski S, Dovedi SJ, Cobbold M. An affinity-modulated T cell engager targeting Claudin 18.2 shows potent anti-tumor activity with limited cytokine release. J Immunother Cancer. 2025 Aug 4;13(8):e011857. doi: 10.1136/jitc-2025-011857.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD5863 and AZD2936 in people with Gastric Cancer and Gastro-esophageal Junction Cancer, run by AstraZeneca at 25 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in South Korea, United Kingdom, United States, China, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with adverse events (time frame: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.