Status:
RECRUITING
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
Lead Sponsor:
AstraZeneca
Conditions:
Gastric Cancer
Gastro-esophageal Junction Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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-cance...
Detailed Description
This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06005493
Start Date
July 11 2023
End Date
June 15 2027
Last Update
September 29 2025
Active Locations (25)
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1
Research Site
Jacksonville, Florida, United States, 32224
2
Research Site
Rochester, Minnesota, United States, 55905
3
Research Site
New York, New York, United States, 10065
4
Research Site
Beijing, China, 100142