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Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06005493•AstraZeneca

View on ClinicalTrials.gov

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.

Detailed Description

This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumors. Each module contains dose-escalation (Part A) and dose-expansion (Part B).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (25)

Research Site

Jacksonville, Florida, United States

Research Site

Rochester, Minnesota, United States

Research Site

New York, New York, United States

Research Site

Beijing, China

Research Site

Beijing, China

Research Site

Shandong, China

Research Site

Toulouse, France

Research Site

Villejuif, France

Research Site

Chūōku, Japan

Research Site

Kashiwa, Japan

Key Dates

Start Date

July 11, 2023

Primary Completion Date

July 16, 2027

Completion Date

July 16, 2027

Last Updated

February 24, 2026

Enrollment

280

ESTIMATED participants

Conditions

Gastric CancerGastro-esophageal Junction CancerPancreatic Ductal AdenocarcinomaEsophageal Adenocarcinoma

Interventions

AZD5863

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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