At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD5863 (drug), AZD2936 (drug)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- AZD5863 — drug: T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells · AZD2936 — drug: Rilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 392
- Started
- 2023-07-11
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for gastric cancer
- • Phase1/Phase2 - 392 participants
- • This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with gastric cancer
Where?
- • Dundee - Research Site
- • London - Research Site
- • Metropolitan Borough of Wirral - Research Site
- • Oxford - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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 2) in patients with advanced or metastatic solid tumors, or AZD5863 in combination with Rilvegostomig (Module 3). Each module contains dose-escalation (Part A) and dose-expansion (Part B).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ received at least one prior line of systemic therapy in the advanced/metastatic setting
- ✓ of systemic therapy in the advanced/metastatic setting
What the study is looking for
- ✓Age ≥ 18 at the time of signing the agreement to take part
- ✓confirmed by a biopsy 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)
- ✓activity scale Performance status (ECOG PS): 0-1 at screening
Who cannot take part
- ✗Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥...
- ✗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...
See the full criteria
Where Is This Study? (4 UK sites)
Research Site
Dundee DD1 9SY, United Kingdom
Research Site
London E1 1BB, United Kingdom
Research Site
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Research Site
Oxford OX3 7LE, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
