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NCT06005493RecruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
392 (estimated)
First submitted
16 Jun 2023
Start date
11 Jul 2023
Primary completion date
16 Mar 2029
Lead sponsor
AstraZeneca
NCT number
NCT06005493
EU CT number
2023-504139-42-00
EudraCT number
2023-000154-20

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 392
  • From 11 Jul 2023 to the primary completion date, 16 Mar 2029
  • 21 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BeijingChinaRecruiting
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ShandongChinaRecruiting
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ToulouseFranceRecruiting
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VillejuifFranceRecruiting
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DundeeUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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Metropolitan Borough of WirralUnited KingdomRecruiting
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OxfordUnited KingdomRecruiting
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ChūōkuJapanRecruiting
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KashiwaJapanRecruiting
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KōtokuJapanRecruiting
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SeoulSouth KoreaRecruiting
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AmsterdamNetherlandsRecruiting
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GroningenNetherlandsRecruiting
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RotterdamNetherlandsRecruiting
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Kaohsiung CityTaiwanRecruiting
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TainanTaiwanRecruiting
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TaoyuanTaiwanRecruiting
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JacksonvilleUnited StatesRecruiting
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New YorkUnited StatesWithdrawn
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RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.