Ireland
--:--IST
Recruiting Phase 1/2

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

NCT06005493 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 1/2
Started
2023-07-11
Last updated
2026-09-25

Condition(s) studied

Gastric CancerGastro-esophageal Junction CancerPancreatic Ductal AdenocarcinomaEsophageal Adenocarcinoma

Investigational drug(s) / intervention(s)

AZD5863AZD2936 →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The number of patients with adverse events — From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
    Number of patients with adverse events by system organ class and preferred term
  • The number of patients with adverse events of special interest — From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
    Number of patients with adverse events of special interest by system organ class and preferred term
  • The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. — From first dose of study drug until the end of Cycle 1
    A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.
  • The number of patients with serious adverse events — From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
    Number of patients with serious adverse events by system organ class and preferred term
  • Objective Response Rate (ORR) — From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
    The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose expansion only.

Trial sites (25)

FacilityCityRegionStatus
Research Site Jacksonville Florida Recruiting
Research Site Rochester Minnesota Recruiting
Research Site New York New York Withdrawn
Research Site Beijing China Recruiting
Research Site Beijing China Recruiting
Research Site Shandong China Recruiting
Research Site Toulouse France Recruiting
Research Site Villejuif France Recruiting
Research Site Chūōku Japan Recruiting
Research Site Kashiwa Japan Recruiting
Research Site Kōtoku Japan Recruiting
Research Site Amsterdam Netherlands Recruiting
Research Site Groningen Netherlands Recruiting
Research Site Rotterdam Netherlands Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Kaohsiung City Taiwan Recruiting
Research Site Tainan Taiwan Recruiting
Research Site Taoyuan Taiwan Recruiting
Research Site Dundee United Kingdom Recruiting
Research Site London United Kingdom Recruiting
Research Site Metropolitan Borough of Wirral United Kingdom Recruiting
Research Site Oxford United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06005493 on ClinicalTrials.gov ↗ ← All trials in the Netherlands