Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Cla… (NCT05216835) | Clinical Trial Compass
CompletedPhase 1
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
United States, Canada, Denmark45 participantsStarted 2022-03-18
Plain-language summary
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
Who can participate
Age range
16 Years – 101 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:
* ≥ 16 years of age at the time of obtaining informed consent
* Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
* At least one positron emission tomography (PET)-avid measurable lesion according to Modified Lugano Criteria after the last line of therapy.
* Confirmed histological diagnosis of active relapse/refractory cHL
* Failed at least 2 prior lines of systemic therapy.
* No previous treatment with anti-TIM-3.
* Adequate organ and bone marrow function
* Non-pregnant women and willingness of female patients to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
* Minimum body weight ≥ 40 kg for all participants.
Exclusion Criteria:
* Unresolved toxicities of ≥ Grade 2 from prior therapy
* Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy
* Patients with central nervous system (CNS) involvement or leptomeningeal disease.
* History of allogeneic stem cell transplant or organ transplantation.
* Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose of study intervention.
* Active infection including Tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
* History of arrhythmia which is requires treatment, symptomatic or uncontrol led atrial fibrillation despite treatment, or asymptomatic sustain…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Timeframe: From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
2
Part A (Dose Escalation): Number of Participants With Dose-limiting Toxicities (DLTs)
Timeframe: From first dose (C1D1) until 28 days for each participant [within 28 days DLT period]
3
Part B (Dose Expansion): Cohort B1: Objective Response Rate (ORR)
Timeframe: Up to approximately 2 years 90 days
4
Part B (Dose Expansion): Cohort B2: Complete Response Rate (CRR)
Timeframe: Up to approximately 2 years 90 days
5
Part B (Dose Expansion): Number of Participants With AEs