A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic … (NCT05123482) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
United States, Australia, Belgium460 participantsStarted 2021-10-18
Plain-language summary
This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone 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.
Inclusion criteria
. Cohort B1 (Biliary Tract Cancer)
. Cohort B2 (Ovarian Cancer)
. Cohort B3 (Breast Cancer)
. Cohort B4 (Endometrial Cancer)
. Cohort B5 (Squamous Non-Small Cell Lung Cancer)
Exclusion criteria
. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment
. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment
. Any other anticancer treatment within the following time periods prior to the first dose of study intervention:
. Cytotoxic treatment: 21 days
. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
. Biological products including immuno-oncology agents: 28 days
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 this is a Phase I/IIa trial and the primary outcomes are focused on measuring side effects, dose-limiting toxicities, and safety signals rather than whether the drug shrinks tumors, what does that mean for what we'd realistically hope to learn from my participation?
2AZD8205 can be given alone or in combination with another agent in this trial — which approach would apply to me given my specific cancer type and situation, and how does the combination affect the safety profile compared to AZD8205 alone?
3The trial is actively monitoring serious adverse events, ECG changes, and lab abnormalities — are there any known or early signals from this drug's mechanism that I should be aware of before deciding whether to discuss enrolling?
4How does my specific cancer diagnosis — whether it's breast, ovarian, endometrial, biliary tract, or squamous non-small cell lung cancer — affect how well I might fit the eligibility criteria for this study, and are there any prior treatment requirements I'd need to meet?
5Given that this is an early-phase trial still establishing safe dosing, would my doctor recommend considering standard treatment options first, or is there a reason this trial might make sense to explore at this point in my care?
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
The number of patients with adverse events
Timeframe: From time of Informed consent to 30 days post last dose (approximately 1 year).
2
The number of patients with serious adverse events
Timeframe: From time of Informed consent to 30 days post last dose (approximately 1 year)
3
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
Timeframe: From first dose of study treatment until the end of Cycle 1 (approximately 21 days).
4
The number of patients with changes from baseline laboratory findings, ECGs and vital signs
Timeframe: From time of informed consent to 30 days post last dose (approximately 1 year)
. History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic sustained ventricular tachycardia.