A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors
NCT ID: NCT06130553
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
234 participants
INTERVENTIONAL
2024-01-18
2026-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AZD3470 Monotherapy
Part A dose escalation and back-fill cohorts and Part B dose optimization and expansion cohorts of varying doses of AZD3470
AZD3470
AZD3470 is a novel, potent and selective, second-generation, MTAP-selective, inhibitor of PRMT5.
Interventions
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AZD3470
AZD3470 is a novel, potent and selective, second-generation, MTAP-selective, inhibitor of PRMT5.
Eligibility Criteria
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Inclusion Criteria
* Willing to provide archival and/or baseline tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing.
* Participants must have received and progressed, are refractory or are intolerant to standard therapy for the specific tumor type. All participants are required to have had at least one prior line of treatment in the recurrent or metastatic setting.
* MTAP deficient tumors defined as evidence of homozygous deletion of one or more exons of the MTAP gene in tumor tissue AND/OR loss of MTAP expression in the tumor tissue.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* A minimum life expectance of 12 weeks in the opinion of the Investigator.
* Participants must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Adequate organ and bone marrow reserve function.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
* Allogeneic organ transplantation.
* Any significant laboratory finding or any severe and uncontrolled medical condition.
* Any of the following cardiac criteria:
* LVEF ≤ 50%
* prior or current cardiomyopathy
* clinically active cardiovascular disease, or a history of myocardial infarction within the last 6 months
* uncontrolled angina or acute coronary syndrome within 6 months
* severe valvular heart disease
* uncontrolled hypertension
* risk of brain perfusion problems. Stroke or transient ischemic attack in the last 6 months, undergone coronary artery bypass graft, angioplasty or vascular stent
* chronic heart failure
* factors that increase the risk of QTc prolongation or risk of arrhythmic events
* Mean resting QTcF \> 470 msec or any clinically important abnormalities in rhythm
* Use of therapeutic anti-coagulation for treatment of acute thromboembolic events.
* Serologic active hepatitis B or C infection.
* Known to have tested positive for Human immunodeficiency virus (HIV).
* Confirmed or suspected ILD/pneumonitis or history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen
* Active gastrointestinal disease or other condition that would interfere with oral therapy.
* History of another primary malignancy.
* Unresolved toxicities from prior anti-cancer therapy, except alopecia and neuropathy.
* Prior treatment with a protein arginine methyltransferase 5 (PRMT5) inhibitor .
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
San Francisco, California, United States
Research Site
West Hollywood, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Baltimore, Maryland, United States
Research Site
Portland, Oregon, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Providence, Rhode Island, United States
Research Site
Fairfax, Virginia, United States
Research Site
Melbourne, , Australia
Research Site
Beijing, , China
Research Site
Chengdu, , China
Research Site
Shanghai, , China
Research Site
Villejuif, , France
Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Amsterdam, , Netherlands
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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165618
Identifier Type: REGISTRY
Identifier Source: secondary_id
D9970C00001
Identifier Type: -
Identifier Source: org_study_id