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Clinical Trials in the UK / NCT06005493
Recruiting Phase 1/2

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

NCT06005493 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 1/2
Started
2023-07-11
Last updated
2026-02-24

Condition(s) studied

Gastric CancerGastro-esophageal Junction CancerPancreatic Ductal AdenocarcinomaEsophageal Adenocarcinoma

Investigational drug(s) / intervention(s)

AZD5863

AZD5863: T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Research Site Jacksonville Florida Recruiting
Research Site Rochester Minnesota Recruiting
Research Site New York New York 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06005493 on ClinicalTrials.gov ↗ ← All trials in the UK