First in Human Study of AZD9592 in Solid Tumors (NCT05647122) | Clinical Trial Compass
Active — Not RecruitingPhase 1
First in Human Study of AZD9592 in Solid Tumors
United States, Australia, Canada167 participantsStarted 2022-12-21
Plain-language summary
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* Life expectancy ≥ 12 weeks
* Measurable disease per RECIST v1.1
* Adequate organ and marrow function as defined in the protocol
Additional Inclusion Criteria for Module 1:
• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.
Additional Inclusion Criteria for Module 2:
• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.
Additional Inclusion Criteria for Module 3:
• Histologically or cytologically confirmed metastatic CRC.
Key Exclusion Criteria:
* History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Spinal cord compression or a history of leptomeningeal carcinomatosis.
* Active infection including tuberculosis and HBV, HCV or HIV
* Brain metastases unless treated (prior treatment required only for Module 1), asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 2 weeks prior to start of study treatment.
* Participants with cardiac comorbidities as defined in the study protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since AZD9592 is being tested in humans for the first time in this Phase 1 trial, and the study is primarily measuring side effects and safe dosing rather than confirming that it works — what does that mean for the balance of potential risk versus potential benefit for someone in my situation?
2This trial is listed as 'active but no longer recruiting,' which means they aren't taking new patients right now — are there any similar early-phase studies testing AZD9592 or drugs like it that I might still be eligible to join?
3The trial is tracking serious adverse events and dose-limiting toxicities as its main focus — based on what's been reported so far for this drug, are there any safety signals you'd want me to be aware of before I consider this type of treatment?
4My cancer type is one of the conditions this trial targets — whether it's non-small cell lung cancer, head and neck, or colorectal — but would standard approved treatments still be a better first step for me before considering an experimental first-in-human drug?
5One of the things they're measuring is whether tumors actually respond on imaging (called objective response rate) — has any early data from this trial been shared publicly that you've seen, and what would it mean for my specific cancer type?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events (AEs)
Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592
2
Incidence of Serious Adverse Events (SAEs)
Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592
3
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Timeframe: From time of first dose of AZD9592 to end of DLT period (approximately 21 days)
4
Incidence of baseline laboratory finding, ECG and vital signs changes
Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592
5
Proportion of patients with radiological response (ORR)
Timeframe: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)