RECRUITING

A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors

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Conditions

Advanced Solid Tumors That Are MTAP Deficientsolid tumorMTAP deficient

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PRIMROSE: A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumors That Are MTAP Deficient

Quick Facts

Study Start:2024-01-18
Study Completion:2026-02-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06130553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Willing to provide archival and/or baseline tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing.
  3. * 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.
  4. * 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.
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  6. * A minimum life expectance of 12 weeks in the opinion of the Investigator.
  7. * Participants must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  8. * Adequate organ and bone marrow reserve function.
  9. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  1. * Spinal cord compression or symptomatic and unstable brain metastases or leptomeningeal disease or primary malignancies of the central nervous system.
  2. * Allogeneic organ transplantation.
  3. * Any significant laboratory finding or any severe and uncontrolled medical condition.
  4. * Any of the following cardiac criteria:
  5. * LVEF ≤ 50%
  6. * prior or current cardiomyopathy
  7. * clinically active cardiovascular disease, or a history of myocardial infarction within the last 6 months
  8. * uncontrolled angina or acute coronary syndrome within 6 months
  9. * severe valvular heart disease
  10. * uncontrolled hypertension
  11. * risk of brain perfusion problems. Stroke or transient ischemic attack in the last 6 months, undergone coronary artery bypass graft, angioplasty or vascular stent
  12. * chronic heart failure
  13. * factors that increase the risk of QTc prolongation or risk of arrhythmic events
  14. * Mean resting QTcF \> 470 msec or any clinically important abnormalities in rhythm
  15. * Use of therapeutic anti-coagulation for treatment of acute thromboembolic events.
  16. * Serologic active hepatitis B or C infection.
  17. * Known to have tested positive for Human immunodeficiency virus (HIV).
  18. * Confirmed or suspected ILD/pneumonitis or history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen
  19. * Active gastrointestinal disease or other condition that would interfere with oral therapy.
  20. * History of another primary malignancy.
  21. * Unresolved toxicities from prior anti-cancer therapy, except alopecia and neuropathy.
  22. * Prior treatment with a protein arginine methyltransferase 5 (PRMT5) inhibitor.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
San Francisco, California, 94143
United States
Research Site
West Hollywood, California, 90048
United States
Research Site
New Haven, Connecticut, 06510
United States
Research Site
Baltimore, Maryland, 21231
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Pittsburgh, Pennsylvania, 15232
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-18
Study Completion Date2026-02-26

Study Record Updates

Study Start Date2024-01-18
Study Completion Date2026-02-26

Terms related to this study

Keywords Provided by Researchers

  • solid tumor
  • MTAP deficient

Additional Relevant MeSH Terms

  • Advanced Solid Tumors That Are MTAP Deficient