Study identifier:D8410C00001
ClinicalTrials.gov identifier:NCT05417594
EudraCT identifier:2021-006227-17
CTIS identifier:N/A
A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1)
Advanced solid malignancies
Phase 1/2
No
AZD9574, Temozolomide, [11C]AZ1419 3391
All
270
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2023 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Module 1 Part A: Dose escalation Participants with advanced/relapsed ovarian, breast, pancreatic, or prostate cancer who are deemed suitable for a PARPi will receive AZD9574 monotherapy at escalating cohorts. | Drug: AZD9574 Participants will receive AZD9574 orally in both the modules. |
Experimental: Module 1 Part B: Dose expansion Participants with breast cancer who are PARPi naive at a dose determined in dose-escalation. | Drug: AZD9574 Participants will receive AZD9574 orally in both the modules. |
Experimental: Module 2 Part A: Dose escalation Participants with IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts. | Drug: AZD9574 Participants will receive AZD9574 orally in both the modules. Drug: Temozolomide Participants will receive temozolomide orally. |
Experimental: Module 3 Panel 1: AZD9574 monotherapy (Sweden only) Participants with advanced/relapsed HER2-negative breast, ovarian, prostate, or pancreatic cancer and expressing BRCA1m, BRCA2m, PALB2m, RAD51Cm or RAD51Dm. | Drug: [11C]AZ1419 3391 Participants will receive [11C]AZ1419 3391 intravenously. |
Experimental: Module 3 Panel 2: AZD9574 + TMZ (Sweden only) Participants with IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts. | Drug: [11C]AZ1419 3391 Participants will receive [11C]AZ1419 3391 intravenously. |
Experimental: Module 3 Panel 3: AZD9574 monotherapy (Sweden only) Participants with breast cancer (without BM). | Drug: [11C]AZ1419 3391 Participants will receive [11C]AZ1419 3391 intravenously. |