Status:
RECRUITING
AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.
Lead Sponsor:
AstraZeneca
Conditions:
Lymphoma
Non-Hodgkin
Eligibility:
All Genders
15+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in p...
Detailed Description
This is a FTiH modular, Phase I/II, open-label, multicentre, dose escalation and expansion study in participants with r/r haematologic malignancies. The study is designed to evaluate the safety, toler...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Adequate organ and bone marrow function.
- In Part A (dose escalation), participants must be aged ≥ 18 years at the time of signing the informed consent. In Part B (dose optimization/expansion), participants must be at least 15 years of age.
- Histologically confirmed documented diagnosis of r/r cHL based on criteria established by the World Health Organization
- Must provide FFPE baseline tumour tissue to meet the minimum tissue requirement for central MTAP expression determination.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Module 1 (cHL):
- At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion \> 1.5 cm.
- Participants must have documented r/r active disease, must have previously received at least 3 prior lines of therapy (including Brentuximab Vedotin and anti-PD-1 therapy) for the treatment of cHL, and must have exhausted all available therapies with demonstrated clinical benefit.
- Exclusion criteria
- Any significant laboratory finding or any severe and uncontrolled medical condition.
- Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
- Serologic active HBV or HCV infection.
- Known to have tested positive for HIV.
- Active gastrointestinal disease or other condition that will interfere with oral therapy.
- Any of the following cardiac criteria:
- Mean resting QTcF \> 470 msec or clinically important abnormalities in rhythm (ventricular arrhythmias and uncontrolled atrial fibrillation)
- Factors that increase the risk of QTc prolongation or risk of arrhythmic events
- Cardiac procedures or conditions within the last 6 months: Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) or heart valve intervention vascular stent implantation, acute coronary syndrome / myocardial infarction, uncontrolled angina pectoris, use of therapeutic anti-coagulation for treatment of active thromboembolic events.
- Severe valvular heart disease
- Congestive heart failure Grade II to Grade IV
- Prior or current cardiomyopathy
- Uncontrolled hypertension
- Brain perfusion problems such as haemorrhagic or thrombotic stroke (including transient ischemic attacks)
- Unresolved non-haematological toxicities of Grade \> 1 from prior anticancer therapy (excluding peripheral neuropathy, vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy, and asymptomatic laboratory abnormalities), unless immune-mediated.
- History of another primary malignancy.
- History of significant haemoptysis or haemorrhage within 4 weeks of the first dose of study treatment.
- Requires ongoing immunosuppressive therapy, including systemic corticosteroids.
- Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
Exclusion
Key Trial Info
Start Date :
January 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06137144
Start Date
January 23 2024
End Date
May 8 2026
Last Update
June 12 2025
Active Locations (20)
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1
Research Site
Miami, Florida, United States, 33136
2
Research Site
Atlanta, Georgia, United States, 30322
3
Research Site
Boston, Massachusetts, United States, 02215
4
Research Site
Philadelphia, Pennsylvania, United States, 19104