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Study of AZD5863 for Advanced Solid Tumors

This study is testing a new treatment called AZD5863 for adults with advanced or metastatic (spread to other parts of the body) gastric (stomach), gastro-esophageal junction, esophageal (food pipe), or pancreatic cancer. AZD5863 is a T cell-engaging bispecific antibody, which means it's designed to help your body's immune cells (T cells) find and fight cancer cells that have a specific marker called CLDN18.2. The main goals are to see if AZD5863 is safe and tolerable, and if it shows any anti-cancer activity. You may be able to join if you are 18 or older, have one of these cancer types, and your tumor shows the CLDN18.2 marker. This study is currently recruiting about 280 participants.

Study design
This is a Phase I/II, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve about 280 participants and tests AZD5863 given either intravenously (into a vein) or subcutaneously (under the skin).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 90 days after your last dose of the study drug, or until you start another anti-cancer treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06005493

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~280 participants
Updated 2026-02-24 on ClinicalTrials.gov
What's tested:AZD5863

At a glance

Recruiting sites
24 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of patients with adverse events
Measured over From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
+4 more outcomes measured

Conditions

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

Explore related trials

Esophageal AdenocarcinomaGastric CarcinomaGastroesophageal Junction CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmClaudin-18 Isoform A2

Where it's being run

25 sites across 10 states
South Korea4
United Kingdom4
China3
Japan3
Netherlands3
Taiwan3
France2
Florida1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • The number of patients with adverse eventsFrom 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 interestFrom 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.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 eventsFrom 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)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.