For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. Age ≥ 18 at the time of signing the informed consent
  2. Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
  3. Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  4. Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)
  5. Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
  6. Predicted life expectancy of ≥ 12 weeks
  7. Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol
  8. Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol
  9. Must have received at least one prior line of systemic therapy in the advanced/metastatic setting

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
  2. 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
  3. Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
  4. Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
  5. central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
  6. Infectious disease including active human immunodeficiency virus (HIV), active hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection
  7. Cardiac conditions as defined by the protocol
  8. History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
  9. Participant requires chronic immunosuppressive therapy
  10. Participants on anticoagulation therapy

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study Details


Contition

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

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

200

Est. Completion Date

Dec 11, 2026

Treatment Type

INTERVENTIONAL


Sponsor

AstraZeneca

ClinicalTrials.gov NCT Identifier

NCT06005493

Study Number

D9750C00001

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