Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06005493 | Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | 280 | — | — | Jul 11, 2023 | Jul 16, 2027 | Feb 24, 2026 | 25 | United States, China +6 |
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...