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Experimental treatment for advanced solid tumors using AZD5863

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

Phase1; Phase2 Interventional AstraZeneca · NCT06005493

This study is testing a new treatment called AZD5863 to see if it can help adults with advanced solid tumors that have a specific marker in their cancer cells.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment280 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR-T, chimeric antigen receptor
Locations25 sites (Jacksonville, Florida and 24 other locations)
Trial IDNCT06005493 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and anti-cancer activity of AZD5863, a T cell-engaging bispecific antibody targeting Claudin 18.2 and CD3, in adult patients with advanced or metastatic solid tumors. The study is structured in two modules: one administering AZD5863 intravenously and the other subcutaneously, with each module including dose-escalation and dose-expansion phases. Participants must have a confirmed diagnosis of specific adenocarcinomas and show positive expression of CLDN18.2 in their tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced gastric, gastro-esophageal junction, pancreatic, or esophageal adenocarcinomas that express CLDN18.2.

Not a fit: Patients with unresolved toxicity from prior anticancer therapies or those without measurable lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors expressing CLDN18.2.

How similar studies have performed: Other studies utilizing T cell-engaging bispecific antibodies have shown promise, suggesting potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Jacksonville, Florida and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastric CancerGastro-esophageal Junction CancerPancreatic Ductal AdenocarcinomaEsophageal AdenocarcinomaCLDN18.2 / Claudin 18.2CD3T cell-engaging bi-specific antibodyGastric cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.