Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

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).

Conditions

Solid Tumor

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Study Overview

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Study Details

Study overview

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).

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

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Honor Health Research Institute, Scottsdale, Arizona, United States, 85258

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Duarte

City of Hope, Duarte, California, United States, 91010

Santa Rosa

Providence Medical Group, Santa Rosa, California, United States, 95403

Celebration

Advent Health, Celebration, Florida, United States, 34747

Orlando

Orlando Health Cancer Institute, Orlando, Florida, United States, 32806

Indianapolis

Indiana University Health Hospital, Indianapolis, Indiana, United States, 46202

Lexington

Markey Cancer Center, Lexington, Kentucky, United States, 40536

Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States, 21287

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02115

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must be at least 18 years of age
  • * Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
  • * Have evidence of homozygous loss of MTAP or MTAP deletion
  • * Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns
  • * Measurable disease
  • * ECOG performance status \<= 1
  • * Adequate organ function
  • * Able to swallow and retain orally administered study treatment
  • * Recovery from acute effects of prior therapy
  • * Able to comply with contraceptive/barrier requirements
  • * Known symptomatic brain metastases
  • * Known primary CNS malignancy
  • * Current active liver or biliary disease
  • * Impairment of gastrointestinal (GI) function
  • * Active uncontrolled infection
  • * Clinically significant cardiac abnormalities
  • * Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
  • * Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
  • * Radiation therapy within 2 weeks prior to study entry
  • * Prior irradiation to \>25% of the bone marrow
  • * Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
  • * Currently receiving another investigational study drug.
  • * Known or suspected hypersensitivity to IDE397/excipients or components

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

IDEAYA Biosciences,

Jasgit Sachdev, MD, STUDY_DIRECTOR, IDEAYA Biosciences

Study Record Dates

2027-03-30