← Back to Search

Other

AZD9574 for Advanced Solid Tumors (CERTIS1 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have progressed following at least one prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment option
Participants must have one of the following: 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; 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; Histologically or cytologically confirmed advanced/metastatic castration-resistant prostate cancer (CRPC) 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; Histologically or cytologically confirmed advanced/metastatic pancreatic 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until disease progression or death (approximately three years)
Awards & highlights

CERTIS1 Trial Summary

This trial will study the effects of AZD9574 on patients with advanced cancer.

Who is the study for?
This trial is for adults with advanced solid tumors that have worsened despite previous treatments. They must be in stable condition, not planning to conceive, and have specific genetic mutations related to cancer growth. People who've had certain prior therapies or severe reactions to similar drugs, uncontrolled diseases, or are unable to take oral medications cannot join.Check my eligibility
What is being tested?
The study tests AZD9574 alone and combined with other anti-cancer agents (Trastuzumab Deruxtecan, Datopotamab Deruxtecan, Temozolomide) on 490 participants. It aims to evaluate safety and early signs of effectiveness while monitoring how the body processes these drugs.See study design
What are the potential side effects?
Potential side effects include typical drug reactions like nausea and fatigue but may also involve more serious issues such as blood disorders or allergic responses due to the investigational nature of AZD9574 and its combinations.

CERTIS1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition worsened after treatment for advanced cancer and I have no other good treatment options.
Select...
I have advanced cancer with a specific gene mutation.
Select...
My breast cancer is HER2-negative with a specific genetic mutation.
Select...
My brain tumor has an IDH1 or IDH2 mutation.
Select...
My cancer is getting worse.
Select...
I am fully active or can carry out light work.
Select...
My physical health hasn't worsened in the last 2 weeks.
Select...
I have at least one cancer lesion that hasn't been treated with radiation or has grown after radiation.
Select...
My cancer can be measured or observed.
Select...
My cancer cannot be removed by surgery or has spread to other parts of my body.
Select...
I can provide a tissue sample from my tumor for testing.
Select...
I am a woman who can have children and have tested negative for pregnancy.
Select...
I have a tumor larger than 10mm that hasn't been treated with radiation.
Select...
My cancer has worsened after radiation and one chemotherapy treatment.
Select...
I have a tumor larger than 10mm that hasn't been treated with radiation.

CERTIS1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of first treatment until the date of objective disease progression or death (approximately three years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of first treatment until the date of objective disease progression or death (approximately three years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline Eastern Cooperative Oncology Group performance status (ECOG PS)
Changes from baseline in laboratory findings, electrocardiograms (ECGs), and vital signs
Incidence of Adverse Events (AEs), and Serious Adverse Events (SAEs)
+1 more
Secondary outcome measures
Accumulation ratio
Area Under the Curve (AUC)
Dose proportionality
+67 more

CERTIS1 Trial Design

8Treatment groups
Experimental Treatment
Group I: Module 5 Part A : Dose escalation (AZD9574 + Dato-DXd)Experimental Treatment2 Interventions
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.
Group II: Module 4 Part A: Dose escalation (AZD9574 + T-DXdat)Experimental Treatment2 Interventions
Participants with advanced, unresectable, or metastatic solid tumours that are HER2-positive will receive a combination of AZD9574 and T-DXdat at escalating cohorts.
Group III: Module 3 Panel 3: AZD9574 monotherapy (Sweden only)Experimental Treatment1 Intervention
Participants with breast cancer (without BM).
Group IV: Module 3 Panel 2: AZD9574 + TMZ (Sweden only)Experimental Treatment1 Intervention
Participants with IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts.
Group V: Module 3 Panel 1: AZD9574 monotherapy (Sweden only)Experimental Treatment1 Intervention
Participants with advanced/relapsed HER2-negative breast, ovarian, prostate, or pancreatic cancer and expressing BRCA1m, BRCA2m, PALB2m, RAD51Cm or RAD51Dm.
Group VI: Module 2 Part A: Dose escalationExperimental Treatment2 Interventions
Participants with IDH 1/2-mutant glioma who are PARPi naive will receive AZD9574 and TMZ at escalating cohorts.
Group VII: Module 1 Part B: Dose expansionExperimental Treatment1 Intervention
Participants with breast cancer who are PARPi naive at doses determined in dose-escalation.
Group VIII: Module 1 Part A: Dose escalationExperimental Treatment1 Intervention
Participants with advanced/relapsed ovarian, breast, pancreatic, or prostate cancer who are deemed suitable for a PARPi will receive AZD9574 monotherapy at escalating cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,491 Total Patients Enrolled

Media Library

AZD9574 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05417594 — Phase 1 & 2
Solid Tumors Research Study Groups: Module 4 Part A: Dose escalation (AZD9574 + T-DXdat), Module 3 Panel 2: AZD9574 + TMZ (Sweden only), Module 1 Part B: Dose expansion, Module 3 Panel 1: AZD9574 monotherapy (Sweden only), Module 2 Part A: Dose escalation, Module 3 Panel 3: AZD9574 monotherapy (Sweden only), Module 5 Part A : Dose escalation (AZD9574 + Dato-DXd), Module 1 Part A: Dose escalation
Solid Tumors Clinical Trial 2023: AZD9574 Highlights & Side Effects. Trial Name: NCT05417594 — Phase 1 & 2
AZD9574 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417594 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research still being accepted?

"Per the information available on clinicaltrials.gov, this medical experiment is actively seeking volunteers; it was initially posted on June 24th 2022 and most recently edited in November 17th of that same year."

Answered by AI

What goals are being sought in this experiment?

"According to AstraZeneca, the primary outcome of this research trial will be monitored across a three year period and is referred to as Incidence of Dose Limiting Toxicities (DLTs). Secondary outcomes include Maximum plasma concentration (Cmax), Duration of Response (DoR) and Accumulation ratio."

Answered by AI

How widely is this experiment being managed across different areas?

"The current list of sites for this trial includes 9 different locations, with 3 being Richmond, La Jolla and Portland. To minimize the impact on your daily life if you choose to join this research study, please select the closest clinic to where you live."

Answered by AI

Are there any eligibility requirements for participation in this trial?

"The experiment is looking to recruit 195 subjects with advanced solid malignancies who have attained the age of consent and are under 130 years old."

Answered by AI

How many participants are being included in the research protocol?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, first posted on June 24th 2022, is actively seeking participants. The study requires 195 patients to be recruited from 9 distinct health centres."

Answered by AI

Does this research project accept individuals aged fifty and above as participants?

"For individuals to be eligible for this trial, they must fit within the age range of 18-130. As a point of comparison, there are 300 trials accepting minors and 2189 that accept seniors."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
2022. "Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05417594.
~233 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top