Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD2811 · 1 trial · 1 indication
Maximum Tolerated Dose (MTD) will be determined in Part A of the study by assessing the incidence of Dose Limiting Toxicities (DLTs), adverse events, and abnormal laboratory results. DLT is defined as: 1. Grade 4 neutropenia for \> 7 days, or febrile neutropenia. 2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding. 3. Concurrent Grade ≥3 total bilirubin, ALT or AST or alkaline phosphatase lasting \> 48 hours, or any change in liver function test results consistent with Hy's Law. 4. Grade ≥3 non-hematologic AE except: a) Grade 3 diarrhoea controlled within 4 days with standard supportive care, b) Grade 3 elevations in ALT/AST that return to meet initial eligibility criteria within 7 days of study drug interruption. 5. Inability to receive all doses in Cycle 1 due to treatment-related toxicity. 6. Non-haematologic toxicity of ≥ Grade 2 (at any time during treatment) that, in the judgment of the Investigator and the Medical Monitor, is dose limiting.
Maximum Tolerated Dose (MTD) will be determined in Part A of the study by assessing the incidence of Dose Limiting Toxicities (DLTs), adverse events, and abnormal laboratory results. At least 3 evaluable patients will be enrolled at each dose level (3+3 design) and will be evaluated for 21 or 28 days before escalation to the next dose level can occur. If one patient experiences a DLT, an additional 3 patients will be treated with the same dose. Therefore, a maximum of up to 6 patients may be enrolled per dose level.
Maximum Tolerated Dose (MTD) will be determined in Part A of the study by assessing the incidence of Dose Limiting Toxicities (DLTs), adverse events, and abnormal laboratory results. At least 3 evaluable patients will be enrolled at each dose level (3+3 design) and will be evaluated for 21 or 28 days before escalation to the next dose level can occur. If one patient experiences a DLT, an additional 3 patients will be treated with the same dose. Therefore, a maximum of up to 6 patients may be enrolled per dose level.
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Part A dose-escalation will evaluate the safety and tolerability of AZD2811 monotherapy at increasing doses in patients with advanced solid tumours. Patients will receive AZD2811 on Days 1 and 4 of a 28-day cycle or Day 1 only in cycles of either 21 or 28 days. |
| Part B | EXPERIMENTAL | Part B will include patients with relapsed or refractory small-cell lung cancer (SCLC). Patients will receive AZD2811 monotherapy at the recommended Phase 2 dose (RP2D). |
| Name | Type | Description |
|---|---|---|
| AZD2811 | DRUG | The study will be conducted in 2 parts, dose-escalation (A) and dose-expansion (B). All patients in both parts of the study with receive AZD2811. |
Inclusion Criteria: Part A Dose Escalation: 1. Histological or cytological confirmation of a solid tumour and disease progression despite standard therapy(ies), or they must be intolerant to standard therapy(ies), or no standard therapy exists. 2. Patients must have received ≤3 prior chemotherapy ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
AZD2811 is an investigational small molecule being studied for the treatment of advanced solid tumours. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety, tolerability, and pharmacokinetics in patients with advanced solid tumours.
AZD2811 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's potential in oncology.
AZD2811 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for advanced solid tumours.
AZD2811 has one completed clinical trial registered under NCT02579226. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of AZD2811 in patients with advanced solid tumours. The trial enrolled 72 participants in the United States and included adults aged 18 years and older.
AZD2811 is a distinct investigational drug developed by AstraZeneca. No alternative names have been reported for this compound. It is being studied specifically for its potential use in treating advanced solid tumours.