AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.

Recruiting now · Phase 1/Phase 2

Conditions studied: Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Peripheral T-cell Lymphoma (PTCL), PTCL-NOS, ALCL, AITL

In brief

This study is designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

Key facts

Study ID

NCT06137144

Run by

AstraZeneca

People needed

161

Starts

2024-01-23

Expected to finish

2029-05-03

Last updated by the study team

2026-06-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Core Inclusion criteria:
• Adequate adult (ECOG) or adolescent (Karnofsy or Lanksy) Performance Score assessments
• Adequate organ and bone marrow function.
• Module 1 Cohort 1:
• Age:
• Part A (dose escalation): aged ≥ 18 years at the time of signing the informed consent.
• Part B (optimization): aged ≥ 12 years of age. Adolescent participants must weigh ≥ 40 kg.
• Histologically confirmed diagnosis of cHL based on WHO criteria
• Previous treatment with at least 2 prior lines of therapy for the treatment of cHL (including at least 2 cycles of BV and anti-PD1) and have documented r/r active disease requiring treatment.
• Participants must provide FFPE baseline tumour tissue.
• At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion ( >1.5 cm for nodal lesion and >1 cm for extranodal lesion).
• Module 1 Cohort 2:
• Participants must be at least 50 years of age or older at study entry.
• Histologically confirmed diagnosis of cHL based on WHO criteria
• Ann Arbor stages III or IV.
• Participant must have previously received at least 4 cycles of SoC combination therapy with A-AVD, N-AVD, AVD, or ABVD (based on regional SOC, per investigator) as finite first-line induction therapy, and achieved at least a PR post-induction therapy.
• Participants must provide FFPE baseline tumour tissue.
• Module 1 Cohort 3:
• Participants must be aged ≥ 18 years at the time of signing the informed consent.
• Histologically confirmed diagnosis of PTCL NOS, systemic ALCL, or AITL based on WHO criteria.
• Participants must have received at least 1 prior line of therapy for the treatment of PTCL and have exhausted all available therapies with demonstrated clinical benefit. Participants with ALCL must have received prior BV treatment.
• Participants must provide FFPE baseline tumour tissue
• a. Ability to provide an on-treatment biopsy (if the tumour is suitable for biopsy).
• At least 1 radiographically measurable, and/or FDG-avid lymphoma lesions (> 1.5 cm for nodal lesion and >1 cm for extranodal lesion).
• Module 2 Cohort 1:

You may not qualify if…

• Core 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 ECG cardiac criteria: Mean resting QTcF > 470 msec, clinically important abnormalities in rhythm, conduction or morphology, and/or any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
• Undergone any of the following procedures within 6 months prior to first dose:
• Coronary artery bypass graft,
• Percutaneous coronary intervention or heart valve replacement or repairment,
• Vascular stent implantation (venous stent is eligible),
• Acute coronary syndrome / myocardial infarction,
• Unstable or poorly controlled angina pectoris,
• Ventricular arrhythmias requiring continuous therapy,
• Uncontrolled atrial fibrillation,
• Haemorrhagic or thrombotic stroke (including transient ischaemic attacks) or any other CNS bleeding.
• Acute venous or atrial thromboembolic event (unless considered stable or adequately treated with at least 3months of therapeutic anticoagulation).
• Severe valvular heart disease.
• Congestive heart failure Grade II to Grade IV.
• Prior or current cardiomyopathy.
• Uncontrolled hypertension.
• History of significant haemoptysis or haemorrhage within4 weeks of the first dose of study treatment.
• Unresolved toxicities of Grade > 1 from prior anti cancer 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.
• Received the following anticancer therapies: anti-lymphoma therapy (within 21 days), radiation therapy(within 28 days), allo-HSCT (within 180 days), auto-HSCT/cellular therapy (within 60 days), or MAT2A or PRMT5 inhibitor

Where it is running

• Research Site — Lille, France (enrolling)
• Research Site — Pierre-Bénite, France (enrolling)
• Research Site — Villejuif, France (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Cologne, Germany (enrolling)
• Research Site — Philadelphia, Pennsylvania, United States (enrolling)
• Research Site — Nedlands, Australia (enrolling)
• Research Site — Alessandria, Italy (enrolling)
• Research Site — Bologna, Italy (enrolling)
• Research Site — Milan, Italy (enrolling)
• Research Site — Houston, Texas, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Seoul, South Korea (enrolling)
• Research Site — Seoul, South Korea (enrolling)
• Research Site — L'Hospitalet de Llobregat, Spain (enrolling)
• Research Site — Madrid, Spain (enrolling)
• Research Site — Manchester, United Kingdom (enrolling)
• Research Site — Oxford, United Kingdom (enrolling)
• Research Site — Kōtoku, Japan
• Research Site — Dijon, France
• Research Site — Atlanta, Georgia, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — New York, New York, United States
• Research Site — Adelaide, Australia
• Research Site — Birtinya, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.