Study on the Safety and Effects of AZD7789 for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Relapsed or Refractory Classical Hodgkin Lymphoma. This is a condition where the cancer has returned or has not responded to previous treatments. The study is testing a new treatment called AZD7789, which is a special type of medicine known as a bispecific antibody. This means it is designed to target two specific proteins, PD-1 and TIM-3, which are involved in the immune system’s response to cancer.

The purpose of the study is to assess the safety and initial effectiveness of AZD7789 in patients with this type of lymphoma. The study is divided into two parts. In the first part, different doses of AZD7789 will be tested to find the safest and most effective dose. In the second part, the study will continue to evaluate the safety and how well the treatment works in a larger group of patients. Some patients in this part of the study will have had previous treatments targeting PD-1 or PD-L1, while others will not have had these treatments before.

Throughout the study, patients will receive AZD7789 through an infusion, which is a way of delivering the medicine directly into the bloodstream. The study will monitor patients for any side effects and changes in their health. The goal is to determine if AZD7789 can help control the cancer and improve the patients’ condition. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the new treatment. The study is expected to continue until 2025.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.

Participants must have a confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma and meet other health and safety requirements.

2 part a: dose escalation

The initial phase involves assessing the safety and tolerability of the medication sabestomig.

Participants receive increasing doses to determine the maximum tolerated dose or the optimal biological dose.

Monitoring includes checking for any adverse effects and changes in vital signs, laboratory results, and heart function.

3 part b: dose expansion

This phase further evaluates the safety and tolerability of sabestomig at the established dose.

Participants are divided into groups based on their previous exposure to certain treatments.

The study observes the medication’s preliminary effects on tumor activity.

4 medication administration

The medication AZD7789 is administered as a solution for infusion.

Other medications such as paracetamol and diphenhydramine are taken orally, while infliximab and tocilizumab are given through intravenous infusion.

In case of emergencies, epinephrine is available for intramuscular injection.

5 monitoring and follow-up

Participants undergo regular monitoring to track the medication’s effects and any side effects.

The study includes assessments of response rates, duration of response, and overall survival at specific time points.

Quality of life and health status are evaluated using standardized questionnaires.

6 completion of the study

The study is estimated to conclude by September 30, 2025.

Final assessments will be conducted to evaluate the long-term effects and overall outcomes of the treatment.

Who Can Join the Study?

Must be at least 16 years old at the time of giving consent to participate.
Should have a performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have at least one measurable area of disease that can be seen on a PET scan, which is a type of imaging test, after the last treatment.
Must have a confirmed diagnosis of active relapsed or refractory classical Hodgkin lymphoma, which means the disease has returned or is not responding to treatment.
Must have tried at least two previous treatments. In some parts of the study, these treatments must include specific types of drugs called anti-PD-1/PD-L1. In other parts, these drugs should not have been used. No previous treatment with anti-TIM-3 is allowed, but treatment with anti-CTLA-4 is okay if it was stopped at least two months before joining the study.
Must have organs and bone marrow that are working well enough to participate.
Women must not be pregnant, and both women and men must agree to use highly effective birth control methods to prevent pregnancy during the study.
Must weigh at least 40 kg (about 88 pounds).

Who Cannot Join the Study?

Patients who have a different type of cancer other than Relapsed/Refractory Classical Hodgkin Lymphoma cannot participate.
Patients who have not been exposed to treatments targeting PD-1/PD-L1 proteins, which are involved in the immune system’s response to cancer, may not be eligible for certain parts of the study.
Patients who have already been exposed to treatments targeting PD-1/PD-L1 proteins may not be eligible for certain parts of the study.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Rigshospitalet	Copenhagen	Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Abdlxfp Uugug Smssdtqqd Lmamrc Dp Bvazqzr	Bologna	Italy
Hwmbfowk Vvpp dryxedad	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	10.03.2022
France	Not recruiting	10.03.2022
Italy	Not recruiting	10.03.2022
Spain	Not recruiting	10.03.2022

Trial locations

Investigated drugs:

AZD7789 is a bispecific antibody designed to target two proteins, PD-1 and TIM-3, which are involved in the immune system’s response to cancer. This medication is being studied for its potential to help the body’s immune system recognize and attack cancer cells in patients with relapsed or refractory classical Hodgkin lymphoma. The trial aims to determine the safety and tolerability of AZD7789, as well as its effectiveness in reducing tumor size or slowing the progression of the disease.

Relapsed/Refractory Classical Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It is characterized by the presence of Reed-Sternberg cells, a type of abnormal cell. The disease is termed “relapsed” when it returns after treatment and “refractory” when it does not respond to treatment. It typically presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing slowly while others may progress more rapidly. The condition requires ongoing monitoring to assess changes in symptoms and disease status.

Trial ID:

2022-502773-41-00

Protocol code:

D9571C00001

NCT ID:

NCT05216835

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of AZD7789 for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

What is this study about?

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