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

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.

Interventions

• AZD5863 · DRUG

  T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (25)

• 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