AZD7789 for Hodgkin's Lymphoma

No longer recruiting at 19 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: CNS involvement, Active infection, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD7789 for individuals with Hodgkin's Lymphoma, specifically those whose cancer has returned or hasn't responded to previous treatments. The main goal is to determine the safety and efficacy of AZD7789. Participants will receive varying doses to identify the optimal dose for future studies. This trial suits individuals who have tried at least two other treatments for Hodgkin's Lymphoma without success and have a confirmed diagnosis of relapsed or refractory classical Hodgkin Lymphoma. As a Phase 1 trial, the research focuses on understanding how AZD7789 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop using any immunosuppressive medication at least 14 days before starting the study treatment. Additionally, you cannot be on any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.

Is there any evidence suggesting that AZD7789 is likely to be safe for humans?

Research has shown that sabestomig (AZD7789) holds promise for patients with relapsed or hard-to-treat classical Hodgkin Lymphoma (r/r cHL). In studies, most patients tolerated the treatment well, experiencing no severe side effects. At a dose of 750 mg, early results were positive for all three patients treated, suggesting that side effects can be managed or minimized. Although these findings are encouraging, sabestomig remains in early testing, and researchers continue to learn about its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD7789 for Hodgkin's Lymphoma because it offers a fresh approach compared to standard treatments like chemotherapy and radiation. Most traditional therapies target the cancer cells directly, often affecting healthy cells as well. However, AZD7789 uses a novel mechanism of action by targeting the PD-1/PD-L1 pathway, which is a crucial part of the immune system. This could potentially enhance the body's natural ability to fight cancer with fewer side effects. Additionally, it’s designed to be effective for patients who have already been exposed to anti-PD-1/PD-L1 therapies or are naïve to such treatments, offering hope to a wider range of patients.

What evidence suggests that AZD7789 might be an effective treatment for Hodgkin's Lymphoma?

Research has shown that treatments targeting the PD-1/PD-L1 pathway can achieve high success rates in patients with relapsed or hard-to-treat classical Hodgkin's Lymphoma (r/r cHL). In this trial, participants will receive Sabestomig (AZD7789), designed to enhance the immune system's ability to combat cancer cells. An early study found that all three patients who received a 750 mg dose responded positively. Sabestomig was well-tolerated, with manageable side effects. These findings suggest that AZD7789 could be a promising treatment for r/r cHL, although further research is needed to confirm its efficacy. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I am 16 years old or older.

Exclusion Criteria

Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment

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

I do not have any unmanaged ongoing illnesses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive sabestomig to determine the recommended phase 2 dose (RP2D)

Up to 2 years 5 months

Cycle 1 Day 1 and subsequent cycles every 28 days

Dose Expansion

Participants receive sabestomig at the RP2D to assess anti-tumor activity

Up to 2 years 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days post last dose

What Are the Treatments Tested in This Trial?

Interventions

• AZD7789

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort B2: Dose Expansion Experimental Treatment 1 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 Expansion Experimental Treatment 1 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 Escalation Experimental Treatment 1 Intervention

Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig to determine the recommended phase 2 dose (RP2D).

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/4433/503389/Safety-and-Preliminary-Efficacy-of-Sabestomig

Safety and Preliminary Efficacy of Sabestomig (AZD7789), an ... Immunotherapies targeting the PD-1/PD-L1 pathway have been shown to induce high response rates in patients with relapsed/refractory (r/r) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05216835

Safety and Preliminary Efficacy Assessment of AZD7789 in ... Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma. ClinicalTrials.gov ID NCT05216835.

3. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D9571C00001

Safety and Preliminary Efficacy Assessment of AZD7789 in ... The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/ ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123110342

Safety and Preliminary Efficacy of Sabestomig (AZD7789), ... Sabestomig was well tolerated with a manageable safety profile. Early efficacy data at 750 mg is encouraging with objective responses in 3/3 patients.

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/35734299/astrazenecas-promising-study-on-azd7789-for-hodgkin-lymphoma-key-insights-for-investors/

AstraZeneca's Promising Study on AZD7789 for Hodgkin ... It is designed to enhance the immune response against cancer cells in patients with r/r cHL. Study Design: The study is interventional, non- ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20536237

Clinical Trials The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/ ...