AZD7789 for Hodgkin's Lymphoma

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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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