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

Official record

Identifier

NCT06005493

Recruiting locations

countries

United StatesChinaFranceJapanNetherlandsSouth KoreaTaiwanUnited Kingdom

Interventions studied

AZD5863AZD2936

Lead sponsor

AstraZeneca

Target enrolment

392 participants

Study type

INTERVENTIONAL

Phase

Phase 1/2

Status

Recruiting

First posted

Aug 22, 2023

Last updated on the registry

Sep 25, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Esophageal Cancer