What is the mechanism of action of this treatment?

The most common treatments for Hodgkin's Lymphoma include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy employs high-energy rays to target and destroy these cells. Immunotherapy, such as PD-1/PD-L1 inhibitors, enhances the immune system's ability to recognize and attack cancer cells. Understanding these mechanisms is important for patients as it provides insight into how their treatment works to fight the disease and what side effects they might encounter.

What side effects are associated with this type of intervention?

Common treatments for Hodgkin's Lymphoma, such as chemotherapy and immunotherapy, are associated with a range of side effects. Chemotherapy can cause pancytopenia, infection, liver toxicity, neuropathy, and long-term complications like secondary malignancies. Immunotherapy, while effective, can lead to immune-related adverse events such as rash, diarrhea, and fatigue. Both treatment types can also result in increased risk of cardiovascular and pulmonary diseases, thyroid dysfunction, and sterility. These side effects highlight the importance of monitoring and managing treatment-related toxicities in patients.

What prior FDA approvals exist?

The FDA has approved several treatments for relapsed or refractory Hodgkin's Lymphoma. Notably, immune checkpoint inhibitors such as nivolumab and pembrolizumab have been approved for patients who have relapsed after autologous stem cell transplantation and brentuximab vedotin. Brentuximab vedotin, an antibody-drug conjugate targeting CD30, is also approved for the treatment of classical Hodgkin's Lymphoma. These treatments focus on enhancing the immune response against cancer cells or directly targeting specific markers on the lymphoma cells.

What other types of research exist?

Promising novel alternatives for Hodgkin's Lymphoma patients in 2024 include: 1) Brentuximab vedotin, an antibody-drug conjugate targeting CD30, which has shown efficacy in relapsed/refractory Hodgkin's Lymphoma. 2) Pembrolizumab and Nivolumab, both PD-1 inhibitors, have demonstrated significant activity in patients with relapsed/refractory Hodgkin's Lymphoma. 3) Combination therapies such as Brentuximab vedotin with immune checkpoint inhibitors (e.g., Nivolumab) are also being explored and have shown promising results.

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Monoclonal Antibodies

AZD7789 for Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

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

Must not have

Uncontrolled intercurrent illness

Other invasive malignancy within 2 years prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AZD7789 for patients whose Hodgkin Lymphoma has come back or didn't respond to previous treatments. The drug is given through an IV, and researchers will check how it works in the body and its effects on the cancer. The goal is to see if it 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.

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.

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 below

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My Hodgkin's lymphoma has returned or is not responding to treatment.

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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.

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I have tried at least 2 different treatments without success.

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I have never been treated with anti-TIM-3 medications.

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I weigh at least 40 kg.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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I have not had any other cancer besides this one in the last 2 years.

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I am not currently receiving any cancer treatments like chemotherapy or radiotherapy.

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I have a heart rhythm problem that needs treatment.

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I have experienced severe side effects from previous immunotherapy.

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I have no ongoing major side effects from previous treatments.

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I do not have any active infections like TB, HIV, hepatitis, or COVID-19.

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I have or had an autoimmune or inflammatory disorder.

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I have a history of lung conditions that required steroid treatment.

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My cancer has spread to my brain or spinal cord.

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I have had an organ or stem cell transplant.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 sabestomig 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 sabestomig once the 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 sabestomig to determine the recommended phase 2 dose (RP2D).

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hodgkin's Lymphoma include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy employs high-energy rays to target and destroy these cells. Immunotherapy, such as PD-1/PD-L1 inhibitors, enhances the immune system's ability to recognize and attack cancer cells. Understanding these mechanisms is important for patients as it provides insight into how their treatment works to fight the disease and what side effects they might encounter.