Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9592 · 1 trial · 4 indications
Number of patients with adverse events by system organ class and preferred term
Number of patients with serious adverse events by system organ class and preferred term
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
measured by laboratory and vital sign variables over time including change from baseline
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only)
| Arm | Type | Description |
|---|---|---|
| Module 1 AZD9592 Monotherapy | EXPERIMENTAL | Module 1 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 as monotherapy in select solid tumors |
| Module 2 AZD9592 Combination with Osimertinib | EXPERIMENTAL | Module 2 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with Osimertinib. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with Osimertinib in NSCLC EGFRm |
| Module 3 AZD9592 Combination 5-FU, Bevacizumab, Leucovorin | EXPERIMENTAL | Module 3 has two parts: Part A aims to determine the safety, tolerability and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC) Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC) |
| Name | Type | Description |
|---|---|---|
| AZD9592 | DRUG | Varying doses of AZD9592 |
| Osimertinib | DRUG | tablets administered orally |
| 5-Fluorouracil (5-FU) | DRUG | IV infusion |
| Leucovorin | DRUG | IV infusion |
| Bevacizumab | DRUG | IV infusion |
Key Inclusion Criteria: * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 * Life expectancy ≥ 12 weeks * Measurable disease per RECIST v1.1 * Adequate organ and marrow function as defined in the protocol Additional Inclusion Criteria for Module 1: • Histological...
| 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 |
AZD9592 is an investigational small molecule being developed for the treatment of advanced solid tumours, including non-small cell lung carcinoma, head and neck neoplasms, and colorectal neoplasms. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AZD9592 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 safety and efficacy of this investigational oncology drug.
AZD9592 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The ongoing Phase 1 trial is designed to assess the drug's safety, tolerability, and preliminary efficacy in patients with advanced solid tumours.
AZD9592 is being studied in a single Phase 1 clinical trial with the identifier NCT05647122, titled 'First in Human Study of AZD9592 in Solid Tumors'. This active, non-recruiting trial has an estimated enrollment of 167 participants and is being conducted across multiple countries including the United States, Australia, Canada, China, France, Italy, Japan, Malaysia, South Korea, Spain, and Taiwan.
AZD9592 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The drug is being evaluated for the treatment of advanced solid tumours, but it has not yet received regulatory approval from the FDA or any other health authority.
The specific molecular target and mechanism of action of AZD9592 have not been disclosed in available information. As a small molecule in oncology development, it is being investigated for its potential to treat advanced solid tumours, but its precise biological target remains undisclosed.