Actively Recruiting
A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors
Led by AstraZeneca · Updated on 2026-05-11
334
Participants Needed
20
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.
CONDITIONS
Official Title
A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants are 18 years or older (or legal consent age) at consent.
- Ability to provide written informed consent and comply with study procedures.
- Willingness to provide tumor tissue for central biomarker testing.
- Tumors must be MTAP deficient based on prior or central testing.
- Have received one or more prior systemic therapies with disease progression.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks as judged by the Investigator.
- Measurable disease per RECIST v1.1 criteria.
- Adequate organ and bone marrow function.
- At least 3 weeks treatment-free interval from prior anticancer therapy.
- Contraception use consistent with local regulations and protocol.
- For Module 2: Confirmed non-squamous NSCLC, Stage IIIB/IIIC or IV not curable.
- For Module 2: Documented extracranial disease progression on or after recent treatment.
- NSCLC mixed histology allowed if not mainly squamous; no small or large cell neuroendocrine components.
- For Module 2: Meet criteria regarding EGFR alteration status and prior systemic therapy as per protocol.
You will not qualify if you...
- Spinal cord compression or symptomatic unstable brain metastases, leptomeningeal disease, or primary CNS cancer.
- History of allogeneic organ transplantation.
- Significant abnormal labs or uncontrolled medical conditions including active infections.
- Clinically significant cardiovascular disease or risk factors.
- Need for therapeutic anticoagulation for acute thromboembolic events.
- Active hepatitis B or C infection with detectable viral load.
- Known HIV infection.
- Current or history of ILD/pneumonitis requiring steroids or oxygen.
- Active gastrointestinal disease or conditions interfering with drug absorption.
- History of another primary cancer.
- Unresolved significant toxicity from prior anticancer therapy.
- Prior treatment with a PRMT5 inhibitor.
- Pregnant, breastfeeding, or intending pregnancy during study.
- For Module 2: Inaccessible veins or inability to place venous access device.
- Contraindication to required brain imaging.
- Clinically significant corneal disease.
- Known active tuberculosis infection.
- Significant fluid accumulation not manageable by drainage.
- Severe pulmonary function compromise.
- Recent radiotherapy not meeting washout or ongoing radiation toxicities needing steroids.
- Prior treatment with prohibited anticancer therapies.
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Research Site
San Francisco, California, United States, 94143
Actively Recruiting
2
Research Site
West Hollywood, California, United States, 90048
Withdrawn
3
Research Site
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Research Site
Baltimore, Maryland, United States, 21231
Actively Recruiting
5
Research Site
Portland, Oregon, United States, 97239
Actively Recruiting
6
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
7
Research Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
8
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Research Site
Melbourne, Australia, 3000
Actively Recruiting
10
Research Site
Beijing, China, 100142
Actively Recruiting
11
Research Site
Chengdu, China, 610041
Actively Recruiting
12
Research Site
Shanghai, China, 200433
Actively Recruiting
13
Research Site
Villejuif, France, 94805
Not Yet Recruiting
14
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
15
Research Site
Kashiwa, Japan, 227-8577
Actively Recruiting
16
Research Site
Amsterdam, Netherlands, 1066CX
Actively Recruiting
17
Research Site
Seoul, South Korea, 03080
Actively Recruiting
18
Research Site
Seoul, South Korea, 06351
Actively Recruiting
19
Research Site
Barcelona, Spain, 8035
Actively Recruiting
20
Research Site
Madrid, Spain, 28027
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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