RECRUITING

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

Conditions

Gastric Cancer Gastro-esophageal Junction Cancer Pancreatic Ductal Adenocarcinoma Esophageal Adenocarcinoma CLDN18.2 / Claudin 18.2 CD3 T cell-engaging bi-specific antibody Solid tumors AZD5863

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-07-11

Study Completion:2026-12-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06005493

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Jacksonville, Florida, 32224

United States

Research Site

Rochester, Minnesota, 55905

United States

Research Site

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-11

Study Completion Date2026-12-11

Study Record Updates

Study Start Date2023-07-11

Study Completion Date2026-12-11

Terms related to this study

Keywords Provided by Researchers

CLDN18.2 / Claudin 18.2
CD3
T cell-engaging bi-specific antibody
Gastric cancer
Gastro-esophageal junction cancer
Pancreatic ductal adenocarcinoma
Solid tumors
AZD5863

Additional Relevant MeSH Terms

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