Recruiting
Phase 1
Phase 2

AZD5863

Sponsor:

AstraZeneca

Code:

NCT06005493

Conditions

Gastric Cancer

Gastro-esophageal Junction Cancer

Pancreatic Ductal Adenocarcinoma

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD5863

AZD2936

Study Details

Brief 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.

Conditions

Gastric Cancer

Gastro-esophageal Junction Cancer

Pancreatic Ductal Adenocarcinoma

Esophageal Adenocarcinoma

Study ID

NCT06005493

Start date

Jul 11, 2023

Status verified date

Sep, 2026

Completion date

Mar 16, 2029

Anticipated

Primary completion date

Mar 16, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Module 3 - Active or ongoing interstitial lung disease / pneumonitis, serious chronic gastrointestinal conditions Module 3 - Any of the following cardiac conditions as determined by investigator: Complex ventricular arrhythmia, symptomatic heart failure, Cardiomyopathy, myocardial infarction or unstable angina (within past 6 months) and uncontrolled hypertension.

Module 3 - Known allergy or hypersensitivity to rilvegostomig or its excipients Module 3 - Prior exposure to an anti-TIGIT therapy

Study Design

Enrollment

392 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1: AZD5863 Monotherapy Intravenous (IV)

Module 1: AZD5863 Intravenous (IV) Monotherapy

experimental: Module 2: AZD5863 Monotherapy Subcutaneous (SC)

Module 2: AZD5863 Subcutaneous (SC) Monotherapy

experimental: Module 3: AZD5863 Combination and Rilvegostomig

Module 3: AZD5863 Combination and Rilvegostomig

Interventions

AZD5863

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

AZD2936

Rilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways.

Primary outcome measure

  • The number of patients with adverse events [ Time Frame: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy ]
  • The number of patients with adverse events of special interest [ Time Frame: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy ]
  • The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. [ Time Frame: From first dose of study drug until the end of Cycle 1 ]
  • The number of patients with serious adverse events [ Time Frame: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy ]
  • Objective Response Rate (ORR) [ Time Frame: From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Jacksonville, Florida, United States, 32224

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

AstraZeneca

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.