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Monoclonal Antibodies
AZD7789 for Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed histological diagnosis of active relapse/refractory cHL
≥ 16 years of age at the time of obtaining informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Study Summary
This trial will test a new drug, AZD7789, on patients with a certain type of cancer that has returned or doesn't respond to treatment. The goal is to see if the drug is safe and effective.
Who is the study for?
This trial is for adults over 18 with relapsed/refractory classical Hodgkin Lymphoma who've had at least two prior systemic therapies and no anti-TIM-3 treatment. They must have a measurable lesion, good performance status, adequate organ/bone marrow function, not be pregnant or fathering children, weigh at least 40 kg, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests AZD7789's safety and effectiveness in patients with relapsed/refractory classical Hodgkin Lymphoma. It will look into how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), tolerability, and preliminary efficacy.See study design
What are the potential side effects?
Potential side effects of AZD7789 are not specified but may include typical reactions to immunotherapy such as fatigue, infusion-related reactions, organ inflammation or immune-mediated adverse events based on similar treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Hodgkin's lymphoma has returned or is not responding to treatment.
Select...
I am 16 years old or older.
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I have at least one cancer lesion visible on a PET scan after my last treatment.
Select...
I have tried at least 2 different treatments without success.
Select...
I have never been treated with anti-TIM-3 medications.
Select...
I weigh at least 40 kg.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A (Dose Escalation): Number of incidence of adverse events (AEs)
Part A (Dose Escalation): Number of patients with dose-limiting toxicities (DLTs)
Part B (Dose Expansion): Cohort B1: Objective response rate (ORR)
+2 moreSecondary outcome measures
Part A (Dose Escalation): Area under the concentration-time curve (AUC)
Part A (Dose Escalation): Complete Response Rate (CRR)
Part A (Dose Escalation): Duration of Complete Response (DoCR)
+19 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort B2: Dose ExpansionExperimental Treatment1 Intervention
Patients with anti-PD-1/PD-L1 naïve r/r cHL will receive AZD7789 once the RP2D has been determined.
Group II: Cohort B1: Dose ExpansionExperimental Treatment1 Intervention
Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive AZD7789 once the recommended phase 2 dose (RP2D) has been determined.
Group III: Cohort A: Dose EscalationExperimental Treatment1 Intervention
Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive AZD7789.
Find a Location
Who is running the clinical trial?
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,646 Total Patients Enrolled
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,801 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Hodgkin's lymphoma has returned or is not responding to treatment.I am 16 years old or older.I have not had any other cancer besides this one in the last 2 years.I have never been treated with anti-TIM-3 medications.I do not have any unmanaged ongoing illnesses.I am not currently receiving any cancer treatments like chemotherapy or radiotherapy.I have a heart rhythm problem that needs treatment.My organs and bone marrow are working well.I haven't taken immunosuppressive drugs in the last 14 days.I have at least one cancer lesion visible on a PET scan after my last treatment.I have tried at least 2 different treatments without success.I have experienced severe side effects from previous immunotherapy.I have no ongoing major side effects from previous treatments.I have not had a blood clot in the past 6 months.I do not have any active infections like TB, HIV, hepatitis, or COVID-19.I have or had an autoimmune or inflammatory disorder.I have a history of lung conditions that required steroid treatment.I have never been treated with anti-TIM-3 medications.I weigh at least 40 kg.My cancer has spread to my brain or spinal cord.I have had an organ or stem cell transplant.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.I have tried at least 2 different treatments without success.My organs and bone marrow are functioning well, as tested within the last week.I have a tumor that shows up on PET scans.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Dose Escalation
- Group 2: Cohort B1: Dose Expansion
- Group 3: Cohort B2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there specific eligibility requirements to take part in this research?
"The age range for patients with lymphoma that are eligible for this study is 18 to 101 years old. Up to 180 people will be accepted into the clinical trial."
Answered by AI
What are the researchers' aims with this experiment?
"The primary objective of this trial, which will last for approximately 2 years, is to assess the complete response rate (CRR) in patients receiving AZD7789. Secondary objectives include measuring the area under the concentration-time curve (AUC) and maximum observed concentration (Cmax) of AZD7789 in patients with relapsed or refractory classical Hodgkin lymphoma (r/r cHL), as well as assessing the duration of response (DoR) to AZD7789 in this patient population."
Answered by AI
Would elderly patients be appropriate for this clinical trial?
"According to the rules set out for this clinical trial, anyone aged 18 or older but not exceeding 101 years old may enroll."
Answered by AI
Are there different facilities conducting this research project in our state?
"At the moment, this research is being conducted in 9 places which are situated in Houston, Vancouver, Montreal and 6 other cities. If you want to cut down on travel, it would be best to select a site near you."
Answered by AI
How many people have been selected to participate in this research project?
"Yes, the trial is still open and actively recruiting patients. 9 different locations across the United States are enrolling a total of 180 patients."
Answered by AI
Are there any open positions for patients in this clinical trial?
"That is correct, the online information hosted on clinicaltrials.gov affirms that this study, which was first advertised on March 18th 2022, is looking for subjects right now. The research needs a total of 180 individuals from 9 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
How old are they?
65+
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
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