Safety and Preliminary Efficacy Assessment of AZD7789 inPatients With Relapsed or Refractory Classical HodgkinLymphoma

Phase 1

• Conditions: Relapsed/Refractory Classical Hodgkin Lymphoma; MedDRA version: 20.1Level: LLTClassification code: 10080208Term: Classical Hodgkin lymphoma Class: 10029104; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2022-502773-41-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-26
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. Must be = 16 years of age at the time of obtaining informed consent, 2. Eastern Cooperative Oncology Group performance status of 0 or 1 at screening, 3. Must have at least one PET-avid measurable lesion according to Modified Lugano Criteria after the last line of therapy., 4. Confirmed histological diagnosis of active relapse/refractory cHL, 5. Must have failed at least 2 prior lines of systemic therapy. In part A dose escalation the prior lines of therapy must include at least 3 cycles of anti-PD- 1/PD-L1 and in part B dose expansion at least 2 cycles of an anti-PD-1/PD-L1. In part B dose expansion cohort B2, prior antiPD-1/PD-L1 therapy is excluded. For all participants, no previous treatment with anti- TIM-3 is allowed. Previous anti-CTLA-4 treatment is acceptable with at least 2 months washout period prior to study entry., 6. Adequate organ and bone marrow function, 7. Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception, 8. Minimum body weight = 40 kg for all participants.

Exclusion Criteria

1. Unresolved toxicities of = Grade 2 from prior therapy, unless immune-mediated., 10. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD or active pneumonitis., 11. Other invasive malignancy within 2 years prior to screening, 12. Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment, 13. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention, 14. Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions is acceptable, 2. Any prior = Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy or any unresolved imAE = Grade 2, 3. Participants with CNS involvement or leptomeningeal disease., 4. History of organ transplant or allogeneic stem cell transplant; autologous stem cell transplant and CAR-T based therapies are permitted if completed >3 months prior to study entry, 5. Any venous or arterial thromboembolic event within = 6 months prior to the first dose of study intervention., 6. Infectious disease exclusions: Active infection including TB, HIV, active hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection, 7. History of arrhythmia which is requires treatment; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, unstable angina pectoris, history of myocardial infarction within the past 6 months, history of myocarditis, serious chronic gastrointestinal conditions associated with diarrhea, active noninfectious skin disease., 9. Active or prior documented pathologically confirmed autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g, colitis or Crohn's disease), diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc. some exceptions have been specified in the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified