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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
AZD9592 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for the treatment of advanced solid tumours. It is currently in Phase 1 clinical development and has not been approved by any regulatory authority. It is being studied in adults with several tumour types, including non-small cell lung cancer, head and neck neoplasms and colorectal neoplasms.
AZD9592 is being studied for the treatment of advanced solid tumours, including carcinoma non-small cell lung, head and neck neoplasms and colorectal neoplasms. It is an investigational agent in Phase 1 development and is not approved for any indication. Use is currently limited to participants enrolled in its clinical trial.
AZD9592 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 first-in-human study evaluating the compound in advanced solid tumours. The company holds the development program for this asset.
AZD9592 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. The single registered trial is a first-in-human Phase 1 study that is currently active but no longer recruiting participants, with a planned enrollment of 190 patients.
AZD9592 is being evaluated in one clinical trial, NCT05647122, titled First in Human Study of AZD9592 in Solid Tumors. The Phase 1 study is active but not recruiting, with an enrollment of 190 participants. It is a controlled study without randomization or double blinding, and it enrolls adults aged 18 years and older across sites in the United States, Australia, Canada, China, France, Italy, Japan, Malaysia, South Korea, Spain and Taiwan.