RecruitingPhase 1Phase 2NCT06005493

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


Sponsor

AstraZeneca

Enrollment

280 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD5863 in adults with advanced or metastatic solid tumors — specifically cancers of the stomach, esophagus, or pancreas that have a protein called CLDN18.2 on their surface. **You may be eligible if:** - You are 18 or older - You have confirmed advanced stomach, gastroesophageal junction, esophageal, or pancreatic cancer - Your tumor tests positive for a protein called CLDN18.2 - You have received at least one prior treatment for advanced/metastatic disease - You are in reasonably good health and your organs are functioning adequately **You may NOT be eligible if:** - You have active autoimmune disease - You have brain metastases within the past 3 months - You have an active infection including HIV, hepatitis B or C - You had a blood clot (DVT or pulmonary embolism) in the past 3 months - You need ongoing immune-suppressing medications - You had a severe reaction to prior T-cell therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD5863

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, Taiwan

Research Site

Dundee, United Kingdom

Research Site

London, United Kingdom

Research Site

Metropolitan Borough of Wirral, United Kingdom

Research Site

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06005493


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