AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematolog… (NCT06137144) | Clinical Trial Compass
RecruitingPhase 1/2
AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.
United States, Australia, China161 participantsStarted 2024-01-23
Plain-language summary
This study is designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.
Who can participate
Age range
12 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
. Adequate adult (ECOG) or adolescent (Karnofsy or Lanksy) Performance Score assessments
. Adequate organ and bone marrow function.
. Age:
. Part A (dose escalation): aged ≥ 18 years at the time of signing the informed consent.
. Part B (optimization): aged ≥ 12 years of age. Adolescent participants must weigh ≥ 40 kg.
. Histologically confirmed diagnosis of cHL based on WHO criteria
. Previous treatment with at least 2 prior lines of therapy for the treatment of cHL (including at least 2 cycles of BV and anti-PD1) and have documented r/r active disease requiring treatment.
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 trial is still in Phase 1/2 and primarily measuring how safe and tolerable AZD3470 is — rather than how well it works — what does that mean for my personal risk if I were to consider enrolling?
2AZD3470 is being tested both alone and in combination with other anticancer agents, so which version of the treatment would I likely be assigned to, and how would that affect what side effects I might experience?
3The trial is specifically looking at dose-limiting toxicities during the escalation phase, which means researchers are still figuring out the right dose — how does that uncertainty compare to the risks of my current standard treatment options?
4Given that this trial focuses on several types of lymphoma including Peripheral T-cell Lymphoma, Hodgkin Lymphoma, and Non-Hodgkin Lymphoma, is my specific diagnosis and disease stage the kind that this study is actually designed to evaluate?
5Before we discuss this trial further, are there any established standard-of-care treatments I should try first, or is my situation one where a Phase 1/2 investigational study like this might be worth considering sooner?
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 and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: From Screening continuously until 28 days after the last dose of study medication.
2
Incidence of DLTs (Dose Escalation Cohorts only)
Timeframe: From first dose of AZD3470 to end of Cycle 1 (each cycle is 21 days).
. Participants must provide FFPE baseline tumour tissue.
Exclusion criteria
. Any significant laboratory finding or any severe and uncontrolled medical condition.
. Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
. Serologic active HBV or HCV infection.
. Known to have tested positive for HIV.
. Active gastrointestinal disease or other condition that will interfere with oral therapy.
. Any of the following ECG cardiac criteria: Mean resting QTcF \> 470 msec, clinically important abnormalities in rhythm, conduction or morphology, and/or any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
. Undergone any of the following procedures within 6 months prior to first dose: