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AZD9574 · 1 trial · 1 indication
The safety and tolerability of AZD9574 as monotherapy and in combination with anti-cancer agents and TMZ in participants with advanced malignancies will be assessed.
The safety and tolerability of AZD9574 as monotherapy and in combination with anti-cancer agents and TMZ in participants with advanced malignancies will be assessed.
The performance status of ECOG will be assessed based on an ECOG grade of 0 to 4 where '0' is a high grade while '4' is a low grade. An ECOG grade of '0' means that the participant is fully active, able to carry on all pre-disease performance without restriction. An ECOG grade of '4' means that the participant is completely disabled, cannot carry on any self-care, and is totally confined to a bed or chair.
The safety and tolerability of AZD9574 as monotherapy and in combination with anti-cancer agents in participants with advanced malignancies will be assessed at each dose level.
| Arm | Type | Description |
|---|---|---|
| Module 1 Part A: Dose escalation | EXPERIMENTAL | Participants with advanced/relapsed ovarian, breast, pancreatic, or prostate cancer who are deemed suitable for a PARPi will receive AZD9574 monotherapy at escalating cohorts. |
| Module 1 Part B: Dose expansion | EXPERIMENTAL | Participants with breast cancer who are PARPi naive at doses determined in dose-escalation. |
| Module 2 Part A: Dose escalation | EXPERIMENTAL | Participants with IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts. |
| Module 3 Panel 1: AZD9574 monotherapy (Sweden only) | EXPERIMENTAL | Participants with advanced/relapsed HER2-negative breast, ovarian, prostate, or pancreatic cancer and expressing BRCA1m, BRCA2m, PALB2m, RAD51Cm or RAD51Dm. |
| Module 3 Panel 2: AZD9574 + TMZ (Sweden only) | EXPERIMENTAL | Participants with IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts. |
| Module 3 Panel 3: AZD9574 monotherapy (Sweden only) | EXPERIMENTAL | Participants with breast cancer (without BM). |
| Module 4 Part A: Dose escalation (AZD9574 + T-DXd) | EXPERIMENTAL | Participants with advanced, unresectable, or metastatic solid tumours that are HER2-positive will receive a combination of AZD9574 and T-DXd at at escalating cohorts. |
| Module 4 Part B : Dose expansion (AZD9574 + T-DXd) | EXPERIMENTAL | Participants with HER2-low/ultralow, HR positive breast cancer will receive a combination of different doses of AZD9574 and T-DXd at expanding cohorts. |
| Module 5 Part A : Dose escalation (AZD9574 + Dato-DXd) | EXPERIMENTAL | Participants with advanced, unresectable, or metastatic solid tumours in different types of cancers will receive a combination of AZD9574 and Dato-DXd at escalating cohorts. |
| Name | Type | Description |
|---|---|---|
| AZD9574 | DRUG | Participants will receive AZD9574 orally. |
| Temozolomide (TMZ) | DRUG | Participants will receive temozolomide orally. |
| [11C]AZ1419 3391 | DRUG | Participants will receive \[11C\]AZ1419 3391 intravenously. |
| Trastuzumab Deruxtecan (T-DXd) | DRUG | Participants will receive T-DXd intravenously. |
| Datopotamab Deruxtecan (Dato-DXd) | DRUG | Participants will receive Dato-DXd intravenously. |
Inclusion Criteria: * Eastern Cooperative Oncology Group performance status (ECOG PS) with no deterioration over the previous 2 weeks. * Progressive cancer at the time of enrollment. * Adequate organ and marrow function. Module 1: Part A: \- Participants must have one of the following: (i) Histo...
AZD9574 is an investigational small molecule being studied for the treatment of advanced solid malignancies. It is currently in Phase 1 clinical development as a monotherapy and in combination with other anti-cancer agents for this patient population.
The specific molecular target of AZD9574 has not been disclosed in the available information. It is a small molecule being evaluated in oncology for advanced solid malignancies, but its mechanism of action is not publicly detailed.
AZD9574 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
AZD9574 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for safety and effectiveness.
AZD9574 is being studied in a Phase 1 clinical trial with the identifier NCT05417594. This trial is recruiting participants with advanced solid malignancies and is being conducted in the United States, Australia, Germany, South Korea, Spain, Sweden, and the United Kingdom.