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Looking for participantsPhase1/Phase2

Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

Sponsor: AstraZeneca

NCT ID: NCT06005493

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD5863 (drug), AZD2936 (drug)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
AZD5863 — drug: T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells · AZD2936 — drug: Rilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
392
Started
2023-07-11
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for gastric cancer
  • • Phase1/Phase2 - 392 participants
  • • This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with gastric cancer

Where?

  • • Dundee - Research Site
  • • London - Research Site
  • • Metropolitan Borough of Wirral - Research Site
  • • Oxford - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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).

Gastric CancerGastro-esophageal Junction CancerPancreatic Ductal AdenocarcinomaEsophageal Adenocarcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

show positive

Treatment history

Treatments you must have had:

  • ✓ received at least one prior line of systemic therapy in the advanced/metastatic setting
  • ✓ of systemic therapy in the advanced/metastatic setting

What the study is looking for

  • ✓Age ≥ 18 at the time of signing the agreement to take part
  • ✓confirmed by a biopsy 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)
  • ✓activity scale Performance status (ECOG PS): 0-1 at screening

Who cannot take part

  • ✗Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥...
  • ✗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...
See the full criteria
Key Inclusion Criteria: * 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 * 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 Key Exclusion Criteria: * 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 * 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

Where Is This Study? (4 UK sites)

Research Site

Dundee DD1 9SY, United Kingdom

Recruiting

Research Site

London E1 1BB, United Kingdom

Recruiting

Research Site

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting

Research Site

Oxford OX3 7LE, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09