Actively Recruiting
A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, and Efficacy of AZD3470, a PRMT5 Inhibitor, as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies
Led by AstraZeneca · Updated on 2026-05-19
161
Participants Needed
35
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD3470, a new oral drug, alone and combined with other anticancer agents in people with blood cancers called haematologic malignancies. This open-label, Phase I/II study aims to assess the safety, tolerability, how the drug moves and works in the body, and early signs of effectiveness. The study includes different groups (modules) focusing on various types and stages of lymphoma and peripheral T-cell lymphoma (PTCL). The study has multiple parts: Module 1 tests AZD3470 alone in adults and adolescents with relapsed or refractory classical Hodgkin lymphoma (cHL), older adults with advanced cHL after frontline therapy, and adults with relapsed or refractory PTCL. Module 2 evaluates AZD3470 combined with pembrolizumab in adults with relapsed or refractory cHL. Each module includes dose escalation and dose optimization phases to find safe and effective doses. Treatment continues during defined cycles or until disease progression or unacceptable side effects. Participants will undergo regular medical assessments, including lab tests, scans to measure tumor response, pharmacokinetic and pharmacodynamic evaluations, and monitoring for side effects throughout treatment and 28 days after the last dose. Researchers will measure outcomes such as adverse events, response rates, duration of response, progression-free and overall survival, and drug concentration in the body. Participants may be followed for long-term safety and treatment effects, with total study duration varying per individual.
CONDITIONS
Brief Title
AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adequate performance score assessments for adults or adolescents
- Adequate organ and bone marrow function
- Module 1 Cohort 1: Age 18 or older for dose escalation; age 12 or older and weighing at least 40 kg for dose optimization; histologically confirmed classical Hodgkin lymphoma (cHL)
- At least 2 prior lines of therapy for cHL including brentuximab vedotin and anti-PD1 treatment
- Provide baseline tumor tissue sample (FFPE)
- At least one measurable or FDG-avid lymphoma lesion
- Module 1 Cohort 2: Age 50 or older with advanced stage (III or IV) cHL
- Received at least 4 cycles of standard first-line therapy and achieved partial or complete response
- Provide baseline tumor tissue sample (FFPE)
- Module 1 Cohort 3: Age 18 or older with histologically confirmed PTCL NOS, ALCL, or AITL
- Received at least 1 prior line of therapy for PTCL with no further beneficial options
- Provide baseline tumor tissue sample and, if suitable, on-treatment biopsy
- At least one measurable or FDG-avid lymphoma lesion
- Module 2 Cohort 1: Age 18 or older with histologically confirmed cHL
- Received at least 1 prior line of therapy for cHL with active disease
- Provide baseline tumor tissue sample (FFPE)
You will not qualify if you...
- Significant laboratory abnormalities or uncontrolled severe medical conditions
- Active central nervous system lymphoma or spinal cord compression
- Active hepatitis B or C infection
- Positive HIV test
- Active gastrointestinal disease interfering with oral therapy
- ECG abnormalities including QTcF over 470 msec or risk factors for arrhythmia
- Recent major cardiac procedures or events within 6 months
- Severe valvular heart disease or congestive heart failure Grade II-IV
- Prior or current cardiomyopathy
- Uncontrolled hypertension
- Recent significant bleeding or hemorrhage
- Unresolved toxicities above Grade 1 from prior cancer therapy except controlled endocrine disorders and certain conditions
- History of another primary malignancy
- Recent anticancer therapies including anti-lymphoma, radiation, stem cell transplants, or PRMT5 inhibitors within specified timeframes
- Requires ongoing immunosuppressive therapy including systemic corticosteroids
- Module 2 Cohort 1 specific: history or evidence of interstitial lung disease or pneumonitis
- Severe immune-related adverse events from prior checkpoint inhibitors
- History of immune-mediated myocarditis or pericarditis
- Prior toxicity causing permanent immunotherapy discontinuation
- Active or prior autoimmune or inflammatory disorders
- Refractory to prior checkpoint inhibitor therapy
- Eligible for stem cell transplant
- Recent allogeneic stem cell transplant within 5 years without graft-versus-host disease
- Known allergy to pembrolizumab or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive AZD3470 as monotherapy or in combination with pembrolizumab. Treatment involves dose escalation and dose optimization/expansion phases to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy. Treatment continues according to protocol-defined cycles (each cycle is 21 days) until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
Regular visits as per protocol-defined treatment cycles
Trial Site Locations
Total: 35 locations
1
Research Site
Duarte, California, United States, 91010
Not Yet Recruiting
2
Research Site
Miami, Florida, United States, 33136
Actively Recruiting
3
Research Site
Atlanta, Georgia, United States, 30322
Withdrawn
4
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Research Site
New York, New York, United States, 10016
Not Yet Recruiting
6
Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
8
Research Site
Adelaide, Australia, 5000
Withdrawn
9
Research Site
Birtinya, Australia, 4575
Withdrawn
10
Research Site
Fitzroy, Australia, 3065
Not Yet Recruiting
11
Research Site
Nedlands, Australia, 6009
Actively Recruiting
12
Research Site
South Brisbane, Australia, 4101
Withdrawn
13
Research Site
Waratah, Australia, 2298
Withdrawn
14
Research Site
Beijing, China, 100191
Not Yet Recruiting
15
Research Site
Guangzhou, China, 510060
Not Yet Recruiting
16
Research Site
Shanghai, China, 20032
Not Yet Recruiting
17
Research Site
Créteil, France, 94010
Terminated
18
Research Site
Lille, France, 59000
Actively Recruiting
19
Research Site
Pierre-Bénite, France, 69310
Actively Recruiting
20
Research Site
Villejuif, France, 94805
Actively Recruiting
21
Research Site
Berlin, Germany, 12203
Not Yet Recruiting
22
Research Site
Cologne, Germany, 50937
Actively Recruiting
23
Research Site
Erlangen, Germany, 91054
Not Yet Recruiting
24
Research Site
Würzburg, Germany, 97080
Not Yet Recruiting
25
Research Site
Alessandria, Italy, 15100
Actively Recruiting
26
Research Site
Bologna, Italy, 40138
Actively Recruiting
27
Research Site
Milan, Italy, 20141
Actively Recruiting
28
Research Site
Bunkyō City, Japan, 113-8677
Not Yet Recruiting
29
Research Site
Kōtoku, Japan, 135-8550
Not Yet Recruiting
30
Research Site
Seoul, South Korea, 03080
Actively Recruiting
31
Research Site
Seoul, South Korea, 06351
Actively Recruiting
32
Research Site
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
33
Research Site
Madrid, Spain, 28041
Actively Recruiting
34
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
35
Research Site
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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