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

Description

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.

Conditions

Gastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Gastric Cancer
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Research Site, Jacksonville, Florida, United States, 32224

Rochester

Research Site, Rochester, Minnesota, United States, 55905

New York

Research Site, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-12-11