Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05417594 | Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies | PHASE1 | RECRUITING | 695 | — | — | Jun 24, 2022 | Oct 13, 2027 | Jun 2, 2026 | 32 | United States, Australia +5 |
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...