RECRUITING

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

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Conditions

Solid TumorMAT2A9p21CDKN2AMTAPSolid TumorsPRMT5SAMSynthetic LethalityInhibitorMTAP deletionCDKN2A deletionMAT2A InhibitorAdvanced solid tumorsLung CancerBladder CancerSquamousNSCLCUrothelial CancerNon small cellDocetaxelPaclitaxelSacituzumab govitecanTrodelvy

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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 Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

Official Title

An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors

Quick Facts

Study Start:2021-04-14
Study Completion:2027-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04794699

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
  2. * Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
  3. * Have evidence of homozygous loss of MTAP or MTAP deletion
  4. * Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns
  5. * Measurable disease
  6. * ECOG performance status \<= 1
  7. * Adequate organ function
  8. * Able to swallow and retain orally administered study treatment
  9. * Recovery from acute effects of prior therapy
  10. * Able to comply with contraceptive/barrier requirements
  1. * Known symptomatic brain metastases
  2. * Known primary CNS malignancy
  3. * Current active liver or biliary disease
  4. * Impairment of gastrointestinal (GI) function
  5. * Active uncontrolled infection
  6. * Clinically significant cardiac abnormalities
  7. * Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
  8. * Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
  9. * Radiation therapy within 2 weeks prior to study entry
  10. * Prior irradiation to \>25% of the bone marrow
  11. * Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
  12. * Currently receiving another investigational study drug.
  13. * Known or suspected hypersensitivity to IDE397/excipients or components

Contacts and Locations

Study Contact

IDEAYA Clinical Trials
CONTACT
+1 650 534 3616
IDEAYAClinicalTrials@ideayabio.com

Principal Investigator

Jasgit Sachdev, MD
STUDY_DIRECTOR
IDEAYA Biosciences

Study Locations (Sites)

Honor Health Research Institute
Scottsdale, Arizona, 85258
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
City of Hope
Duarte, California, 91010
United States
Providence Medical Group
Santa Rosa, California, 95403
United States
Advent Health
Celebration, Florida, 34747
United States
Orlando Health Cancer Institute
Orlando, Florida, 32806
United States
Indiana University Health Hospital
Indianapolis, Indiana, 46202
United States
Markey Cancer Center
Lexington, Kentucky, 40536
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032
United States
Weill Cornell Medical College
New York, New York, 10065
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
LifeSpan - Brown University
Providence, Rhode Island, 02906
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
MD Anderson
Houston, Texas, 77030
United States
Next Oncology
San Antonio, Texas, 78229
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: IDEAYA Biosciences

  • Jasgit Sachdev, MD, STUDY_DIRECTOR, IDEAYA Biosciences

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 Date2021-04-14
Study Completion Date2027-03-30

Study Record Updates

Study Start Date2021-04-14
Study Completion Date2027-03-30

Terms related to this study

Keywords Provided by Researchers

  • MAT2A
  • 9p21
  • CDKN2A
  • MTAP
  • Solid Tumors
  • PRMT5
  • SAM
  • Synthetic Lethality
  • Inhibitor
  • MTAP deletion
  • CDKN2A deletion
  • MAT2A Inhibitor
  • Advanced solid tumors
  • Lung Cancer
  • Bladder Cancer
  • Squamous
  • NSCLC
  • Urothelial Cancer
  • Non small cell
  • Docetaxel
  • Paclitaxel
  • Sacituzumab govitecan
  • Trodelvy

Additional Relevant MeSH Terms

  • Solid Tumor