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RECRUITING
NCT06005493
PHASE1/PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2023-07-11

Completion Date

2027-07-16

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

DRUG

AZD5863

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

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

Research Site

Kōtoku, Japan

Research Site

Amsterdam, Netherlands

Research Site

Groningen, Netherlands

Research Site

Rotterdam, Netherlands

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Kaohsiung City, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taoyuan District, Taiwan

Research Site

Dundee, United Kingdom

Research Site

London, United Kingdom

Research Site

Metropolitan Borough of Wirral, United Kingdom

Research Site

Oxford, United Kingdom