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NCT06005493PHASE1, PHASE2Recruiting

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

AstraZeneca

Start Date

7/11/2023

Completion Date

7/16/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

AZD5863

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Conditions

Gastric CancerGastro-esophageal Junction CancerPancreatic Ductal AdenocarcinomaEsophageal Adenocarcinoma

Locations

Research Site

Jacksonville, Florida 32224

United States

Research Site

Rochester, Minnesota 55905

United States

Research Site

New York, New York 10065

United States

Research Site

Beijing, 100142

China

Research Site

Beijing, 101199

China

Research Site

Shandong,

China

Research Site

Toulouse, 31059

France

Research Site

Villejuif, 94805

France

Research Site

Chūōku, 104-0045

Japan

Research Site

Kashiwa, 227-8577

Japan

Research Site

Kōtoku, 135-8550

Japan

Research Site

Amsterdam, 1081 HV

Netherlands

Research Site

Groningen, 9713 GZ

Netherlands

Research Site

Rotterdam, 3015 GD

Netherlands

Research Site

Seoul, 03080

South Korea

Research Site

Seoul, 03722

South Korea

Research Site

Seoul, 05505

South Korea

Research Site

Seoul, 06351

South Korea

Research Site

Kaohsiung City, 80756

Taiwan

Research Site

Tainan, 70403

Taiwan

Research Site

Taoyuan, 00333

Taiwan

Research Site

Dundee, DD1 9SY

United Kingdom

Research Site

London, E1 1BB

United Kingdom

Research Site

Metropolitan Borough of Wirral, CH63 4JY

United Kingdom

Research Site

Oxford, OX3 7LE

United Kingdom