First-in-Human Study of AZD9592 for Advanced Solid Tumors
This study is testing a new drug called AZD9592 in people with advanced solid tumors, including certain lung, head and neck, and colorectal cancers. This is a "first-in-human" study, meaning it's one of the first times AZD9592 is being given to people. Researchers want to see how safe AZD9592 is, how well your body handles it, and if it shows any signs of fighting cancer, either alone or with other cancer medicines like Osimertinib, 5-Fluorouracil (5-FU), Leucovorin, or Bevacizumab. To join, you need to be at least 18 years old, have a good general health status (ECOG 0-1), and a life expectancy of at least 12 weeks. The main goals are to track any side effects and serious side effects you might experience.
- Study design
- This is a Phase 1, multi-center, open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll about 167 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the time you agree to participate until 30 days after your last dose of AZD9592.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
First in Human Study of AZD9592 in Solid Tumors
At a glance
Conditions
NCT05647122
Where you'd take part
This study runs at 46 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Research Site
Duarte, Californiano site contact published
Research Site
North Haven, Connecticutno site contact published
Research Site
Washington D.C., District of Columbiano site contact published
Research Site
Chicago, Illinoisno site contact published
Research Site
Baltimore, Marylandno site contact published
Research Site
Baltimore, Marylandno site contact published
Research Site
Milford, Massachusettsno site contact published
Research Site
Mineola, New Yorkno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Charu Aggarwal, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Incidence of Adverse Events (AEs)From time of Informed Consent to 30 days post last dose of AZD9592
Number of patients with adverse events by system organ class and preferred term
- Incidence of Serious Adverse Events (SAEs)From time of Informed Consent to 30 days post last dose of AZD9592
Number of patients with serious adverse events by system organ class and preferred term
- Incidence of dose-limiting toxicities (DLT) as defined in the protocolFrom time of first dose of AZD9592 to end of DLT period (approximately 21 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
- Incidence of baseline laboratory finding, ECG and vital signs changesFrom time of Informed Consent to 30 days post last dose of AZD9592
measured by laboratory and vital sign variables over time including change from baseline
- Proportion of patients with radiological response (ORR)From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only)