AZD9574 for Advanced Solid Tumors
(CERTIS1 Trial)
Trial Summary
What is the purpose of this trial?
This trial tests AZD9574, a new drug that stops cancer cells from repairing themselves. It targets patients with advanced or relapsed cancers who need new treatment options. The drug is tested alone and in combination with other cancer-fighting drugs.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that concurrent use of certain medications is prohibited, so it's best to discuss your current medications with the study team to ensure they are not among the restricted ones.
What data supports the effectiveness of the drug AZD9574 for advanced solid tumors?
What safety information is available for AZD9574 (Temozolomide) in humans?
How does the drug AZD9574 differ from other treatments for advanced solid tumors?
AZD9574 is unique because it combines with Temozolomide, a drug known for treating brain tumors and other cancers by damaging cancer cell DNA. This combination may offer a novel approach for advanced solid tumors, potentially enhancing the effectiveness of treatment by leveraging Temozolomide's ability to cross the blood-brain barrier and target cancer cells.12459
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive AZD9574 as monotherapy or in combination with anti-cancer agents in dose-escalation cohorts to assess safety and tolerability.
Dose Expansion
Participants are enrolled in dose-expansion cohorts to further evaluate safety, tolerability, and preliminary efficacy.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AZD9574
- Temozolomide
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Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology