A Phase 1/2 interventional study of AZD5863 and AZD2936 in Gastric Cancer, Gastro-esophageal Junction Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by AstraZeneca. Recruiting at 25 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
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Among 30 studies in Stomach Neoplasms by AstraZeneca — 10 open to participants now, 18 under way, 3 of them phase 3. Stomach Neoplasms · AstraZeneca.
Among the 30 studies in Stomach Neoplasms by AstraZeneca, this one is the 9th largest by planned enrollment of the 27 interventional ones that give a count, is one of 3 that started in 2023, is one of 7 in phase 1/2, reaches primary completion later than 13 of the 17 other live ones, and was the 19th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →10 of the 30 studies in Stomach Neoplasms by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Greece
Ages 18–130
AstraZeneca · Sites in United States, Australia, Austria and 21 more countries
Ages 18+
AstraZeneca · Sites in United States, Australia, Japan and 1 more country
Ages 18+
AstraZeneca · Sites in United States, Canada, China and 8 more countries
Ages 18+
AstraZeneca · Sites in United States, Argentina, Australia and 25 more countries
Ages 18+
By country, each count listing its studies:
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 16 · Phase 3 4
First in 2007; this study’s year is marked. 3 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 392 is above the median of 66 across 2,500 interventional studies indexed under Stomach Neoplasms.
Median enrollment 124 across the 27 interventional studies, 300 across the 3 observational. Of the 12 that completed or were terminated, 4 (33%) have results posted.
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AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
8 of the studies in Stomach Neoplasms by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
| NCT06147037AstraZenecaA Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours | 2026-12-31 |
| NCT06921928AstraZenecaStudy for AZD4360 in Participants With Advanced Solid Tumours | 2027-03-31 |
| NCT04379596AstraZenecaPh1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) | 2027-05-04 |
| NCT04644068AstraZenecaStudy of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies | 2027-05-28 |
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Among the 30 studies in Stomach Neoplasms by AstraZeneca, from their registry updates:
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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.
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).
The criteria were revised on the registry on Sep 25, 2026. See what changed
Key Inclusion Criteria:
Key Exclusion Criteria:
Module 3 - Known allergy or to rilvegostomig or its Module 3 - Prior exposure to an anti-TIGIT therapy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Module 1: AZD5863 Intravenous (IV) Monotherapy
Drug: AZD5863
Module 2: AZD5863 Subcutaneous (SC) Monotherapy
Drug: AZD5863
Module 3: AZD5863 Combination and Rilvegostomig
Drug: AZD5863 · Drug: AZD2936
T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells
Rilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways.
Also known as: Rilvegostomig
The number of patients with adverse events
Number of patients with adverse events by system organ class and preferred term
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
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.
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)
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).
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)
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).
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)
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.
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)
The time from the start of study treatment/date of randomization until death due to any cause.
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)
Maximum observed plasma concentration of the study drug
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)
Area under the plasma concentration-time curve
Time frame: 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.
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)
Terminal elimination half life.
Time frame: 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
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
Measure CLDN18.2 expression (IHC) in baseline and/or on-treatment tumor biopsies and correlate with clinical outcome
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)
Not enrolling at this site — choose another above.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Started Jul 2023 (actual). Primary completion is estimated for Mar 2029, 68 months after the start.
Of 89 industry-sponsored phase 1/2 interventional studies under Stomach Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 109. This study's planned 68 months is above that.
Counting every sponsor, half of 156 studies reached it within 60 months; a quarter within 41 and three quarters within 109.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Jul 2027 → Mar 2029 and completion Jul 2027 → Mar 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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