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) (CERTIS1)
This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics
(PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer
agents in patients with advanced cancer that has recurred/progressed.
This is a modular phase I/IIa, multi-centre, multi-part, open-label, dose escalation, and
dose expansion study.
Approximately 255 participants will be enrolled and assigned to study treatments.
This study consists of individual modules each evaluating safety and tolerability.
Core protocol which contains information applicable to all modules.
Module 1 (AZD9574 monotherapy):
Part A (dose-escalation cohorts) will include participants with advanced/relapsed
ovarian, breast, pancreatic or prostate cancer that are deemed suitable for a Poly
ADP-Ribose Polymerase (PARPi) by the Investigator.
Part B (dose-expansion cohorts):
Cohort B1 will include participants with advanced/relapsed Human Epidermal
Growth Factor Receptor 2 (HER2)-negative breast cancer participants with BRCA
mutated (BRCA1m, and BRCA2m), PALB2 mutation (PALB2m), RAD51Cm or RAD51Dm,
without evidence of brain metastasis at baseline Magnetic Resonance Imaging
Cohort B2 will include participants with advanced/relapsed HER2-negative
breast cancer participants with BRCA1m, BRCA2m, PALB2m, RAD51Cm or RAD51Dm,
who have either untreated or treated brain metastases that are not requiring
immediate local therapy.
Module 2 (AZD9574 in combination with temozolomide (TMZ):
Part A (dose-escalation cohorts) will include participants with Isocitrate
Dehydrogenase (IDH)-mutant glioma.
Dose expansion for Module 2 may be added in the future following a protocol
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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