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NCT06005493From ClinicalTrials.govRecruiting

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

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

  • Gastric Cancer
  • Gastro-esophageal Junction Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Esophageal Adenocarcinoma

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
AstraZeneca
Enrolment target
392
Started
11 July 2023
Main results due
16 March 2029
Study sites
25
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(25)

  • Research Site

    Jacksonville, Florida, United States

    Recruiting

  • Research Site

    Rochester, Minnesota, United States

    Recruiting

  • Research Site

    New York, New York, United States

    Withdrawn

  • Research Site

    Beijing, China

    Recruiting

  • Research Site

    Beijing, China

    Recruiting

  • Research Site

    Shandong, China

    Recruiting

  • Research Site

    Toulouse, France

    Recruiting

  • Research Site

    Villejuif, France

    Recruiting

  • Research Site

    Chūōku, Japan

    Recruiting

  • Research Site

    Kashiwa, Japan

    Recruiting

  • Research Site

    Kōtoku, Japan

    Recruiting

  • Research Site

    Amsterdam, Netherlands

    Recruiting

  • Research Site

    Groningen, Netherlands

    Recruiting

  • Research Site

    Rotterdam, Netherlands

    Recruiting

  • Research Site

    Seoul, South Korea

    Recruiting

  • Research Site

    Seoul, South Korea

    Recruiting

  • Research Site

    Seoul, South Korea

    Recruiting

  • Research Site

    Seoul, South Korea

    Recruiting

  • Research Site

    Kaohsiung City, Taiwan

    Recruiting

  • Research Site

    Tainan, Taiwan

    Recruiting

  • Research Site

    Taoyuan, Taiwan

    Recruiting

  • Research Site

    Dundee, United Kingdom

    Recruiting

  • Research Site

    London, United Kingdom

    Recruiting

  • Research Site

    Metropolitan Borough of Wirral, United Kingdom

    Recruiting

  • Research Site

    Oxford, United Kingdom

    Recruiting

Showing 25 of 25 sites. 24 of the 25 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06005493. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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