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

Launched by ASTRAZENECA · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called AZD5863 for adults with advanced cancer, specifically focusing on types like gastric cancer, gastro-esophageal junction cancer, pancreatic cancer, and esophageal cancer. AZD5863 is a special type of antibody designed to help the immune system target and fight cancer cells. The main goals of the study are to find out if this treatment is safe, how well it works, and if patients can tolerate it without serious side effects.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of one of the specific types of cancer mentioned. They should have at least one measurable tumor and a certain level of a protein called CLDN18.2 in their cancer cells. Participants should also be in relatively good health and have received at least one previous cancer treatment. If someone joins the trial, they can expect regular check-ups and monitoring during the treatment to ensure their safety and assess how well the drug is working. It’s important to know that certain health conditions or recent treatments may exclude someone from participating in this study.

Gender

ALL

Eligibility criteria

• 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