NCT05417594 · AstraZeneca
Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
(CERTIS1)
What this study is about
This study will assess the safety, tolerability, how the drug moves through the body (PK), how the drug affects the body (PD), and preliminary effectiveness of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.
View original scientific description
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 participants with advanced cancer that has recurred/progressed.
Interventions
DRUG
AZD9574
Participants will receive AZD9574 orally.
DRUG
Temozolomide (TMZ)
Participants will receive temozolomide orally.
DRUG
[11C]AZ1419 3391
Participants will receive \[11C\]AZ1419 3391 intravenously.
DRUG
Trastuzumab Deruxtecan (T-DXd)
Participants will receive T-DXd intravenously.
DRUG
Datopotamab Deruxtecan (Dato-DXd)
Participants will receive Dato-DXd intravenously.
Primary outcome measures
Incidence of Adverse Events (AEs), and Serious Adverse Events (SAEs)
Time frame: From first dose to post-treatment follow-up (approximately three years)
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.
Changes from baseline in laboratory findings, electrocardiograms (ECGs), and vital signs
Time frame: From last assessment prior to first dose to post-treatment follow up visit (approximately three years)
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.
Change from baseline Eastern Cooperative Oncology Group performance status (ECOG PS)
Time frame: From last assessment prior to first dose to post-treatment follow up visit (approximately three years)
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.
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: Cycle 0 and Cycle 1 (Day 1 to Day 35)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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) Histologically or cytologically confirmed relapsed advanced ovarian, fallopian tube or primary peritoneal cancer and evidence of a predicted loss of function germline or tumour mutation in one of the following homologous recombination repair genes: BRCA1, BRCA2, PALB2, RAD51C or RAD51D (ii) Histologically or cytologically confirmed HER2-negative carcinoma of the breast with recurrent locally advanced or metastatic disease and evidence of a predicted loss of function germline or tumour mutation in one of the following homologous recombination repair genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D. (iii) Histologically or cytologically confirmed advanced/metastatic castration-resistant prostate canc
Where
- La Jolla, California
- Los Angeles, California
- San Francisco, California
- Chicago, Illinois
- Boston, Massachusetts
- New York, New York
- Portland, Oregon
- Houston, Texas
- San Antonio, Texas
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations