Status:
RECRUITING
A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Solid Tumors That Are MTAP Deficient
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
This first time in human, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency follows a modular design. Module 1 Part A will include...
Eligibility Criteria
Inclusion
- Principle
- Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the ICF.
- 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.
- Principle
Exclusion
- Spinal cord compression or symptomatic and unstable brain metastases or leptomeningeal disease or primary malignancies of the central nervous system.
- 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 .
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 26 2026
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT06130553
Start Date
January 18 2024
End Date
February 26 2026
Last Update
December 17 2025
Active Locations (20)
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1
Research Site
San Francisco, California, United States, 94143
2
Research Site
West Hollywood, California, United States, 90048
3
Research Site
New Haven, Connecticut, United States, 06510
4
Research Site
Baltimore, Maryland, United States, 21231