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Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
Trial Status: active
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).
Inclusion 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
Exclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT04794699.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center