Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Palacaparib
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 being evaluated as a monotherapy and in combination with anti-cancer agents in adult patients with advanced solid tumors. AZD9574 has not been approved for any indication and remains in clinical development.
AZD9574 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating AZD9574 in advanced solid malignancies.
AZD9574 is in Phase 1 clinical development. The ongoing trial is a Phase 1 study evaluating AZD9574 as monotherapy and in combination with anti-cancer agents in participants with advanced solid malignancies. AZD9574 is investigational and has not received regulatory approval.
AZD9574 is being evaluated in the Phase 1 trial NCT05417594, titled Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies. The trial is currently recruiting and has an estimated enrollment of 695 participants across the United States, Australia, Germany, South Korea, Spain, Sweden, and the United Kingdom.
Yes, the AZD9574 Phase 1 trial NCT05417594 is biomarker selected, meaning enrollment is guided by specific biomarker criteria. The study enrolls adults aged 18 years and older with advanced solid malignancies and does not include healthy volunteers.