Status:
RECRUITING
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
Lead Sponsor:
IDEAYA Biosciences
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04794699
Start Date
April 14 2021
End Date
March 30 2027
Last Update
November 12 2025
Active Locations (39)
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1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
2
Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
3
City of Hope
Duarte, California, United States, 91010
4
Hoag Memorial Hospital
Newport Beach, California, United States, 92663