RecruitingPhase 1NCT04794699

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

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

Sponsor

IDEAYA Biosciences

Enrollment

180 participants

Start Date

Apr 14, 2021

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing IDE397, a new targeted drug designed specifically for cancers that are missing a gene called MTAP. MTAP deletion is found in many different cancer types and makes cancer cells vulnerable to a specific kind of drug attack. This study is an early-phase trial checking safety and effectiveness in people with advanced solid tumors. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic solid tumor that has progressed despite at least one prior treatment - Your tumor has been tested and shows homozygous loss of the MTAP gene - Your cancer can be measured on scans - Your overall health is reasonably good (ECOG ≤1) - You are willing to undergo tumor biopsies before and after treatment **You may NOT be eligible if...** - Your tumor does not have MTAP deletion - Your overall health is too poor to tolerate experimental therapy - You are unwilling to undergo biopsy procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIDE397

IDE397 dosed orally

DRUGDocetaxel

Intravenous infusion

DRUGPaclitaxel

Intravenous infusion

DRUGSacituzumab govitecan

Intravenous infusion

Locations(39)

Honor Health Research Institute

Scottsdale, Arizona, United States

Rockefeller Cancer Institute

Little Rock, Arkansas, United States

City of Hope

Duarte, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

Providence Medical Group

Santa Rosa, California, United States

Advent Health

Celebration, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Indiana University Health Hospital

Indianapolis, Indiana, United States

Markey Cancer Center

Lexington, Kentucky, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

LifeSpan - Brown University

Providence, Rhode Island, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

MD Anderson

Houston, Texas, United States

Next Oncology

San Antonio, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

The Kinghorn Cancer Centre, St Vincent's Health Network Sydney

Darlinghurst, New South Wales, Australia

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

Institut Bergonie

Bordeaux, Bordeaux Cedex, France

Institut Claudius Regaud - IUCT-Oncopole

Toulouse, Cedex 9, France

Hôpital Timone

Marseille, Marseille, France

Centre Eugène Marquis

Rennes, France

Universitaetsklinikum Hamburg-Eppendorf (UKE)

Hamburg, Germany

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

CHA University - Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Sevrance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Vall Hebron Institute of Oncology

Barcelona, Spain

Hospital Universitario 12 de Octubre (H12O)

Madrid, Spain

START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, Spain

NEXT Madrid, Universitary Hospital QuironSAlud

Madrid, Spain

Instituto Valenciano de Oncología (IVO)

Valencia, Spain

National Cheng Kung University Hospital

Tainan, Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT04794699

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