Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5863 · 1 trial · 4 indications
Number of patients with adverse events by system organ class and preferred term
Number of patients with adverse events of special interest by system organ class and preferred term
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.
Number of patients with serious adverse events by system organ class and preferred term
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.
| Arm | Type | Description |
|---|---|---|
| Module 1: AZD5863 Monotherapy Intravenous (IV) | EXPERIMENTAL | Module 1: AZD5863 Intravenous (IV) Monotherapy |
| Module 2: AZD5863 Monotherapy Subcutaneous (SC) | EXPERIMENTAL | Module 2: AZD5863 Subcutaneous (SC) Monotherapy |
| Name | Type | Description |
|---|---|---|
| AZD5863 | DRUG | T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells |
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 Tumo...
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AZD5863 is an investigational small molecule being developed for gastric cancer. It is also being studied in gastro-esophageal junction cancer, pancreatic ductal adenocarcinoma, and esophageal adenocarcinoma. The drug is in Phase 1 clinical development and has not been approved by regulatory authorities.
AZD5863 is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of AZD5863 in patients with advanced or metastatic solid tumors.
AZD5863 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in certain types of cancer.
AZD5863 is being evaluated in a Phase 1 clinical trial with the identifier NCT06005493. This study is recruiting adult participants with advanced or metastatic solid tumors, including gastric cancer, gastro-esophageal junction cancer, pancreatic ductal adenocarcinoma, and esophageal adenocarcinoma. The trial is enrolling approximately 280 participants across multiple countries.
AZD5863 is the primary name for this investigational drug. No alternative names have been reported for AZD5863 in the available clinical trial information. It is a unique small molecule being developed by AstraZeneca for the treatment of certain gastrointestinal cancers.