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 |
| Module 3: AZD5863 Combination and Rilvegostomig | EXPERIMENTAL | Module 3: AZD5863 Combination and Rilvegostomig |
| 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 |
| AZD2936 | DRUG | Rilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways. |
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 studied for the treatment of gastric cancer. It is also being evaluated in gastro-esophageal junction cancer, pancreatic ductal adenocarcinoma, and esophageal adenocarcinoma. The drug is in Phase 1 clinical development and has not been approved for any indication.
AZD5863 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sole sponsor of the clinical program evaluating this small molecule in advanced or metastatic solid tumors.
AZD5863 is in Phase 1 clinical development. The only registered trial is a Phase 1 study that is currently recruiting participants. No Phase 2 or Phase 3 trials have been initiated, and the drug remains investigational.
AZD5863 is being evaluated in a single Phase 1 trial, NCT06005493, titled "Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors." The trial is recruiting and has an estimated enrollment of 392 participants across the United States, China, France, Japan, Netherlands, South Korea, Taiwan, and the United Kingdom.
No, AZD5863 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development for gastric cancer and other advanced solid tumors. The only active trial, NCT06005493, is currently recruiting participants and has not yet been completed.