Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
NCT04794699 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 169
Last updated 2026-04-09
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 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
Interventions
- DRUG
-
IDE397 dosed orally
- DRUG
-
Intravenous infusion
Sponsors & Collaborators
-
IDEAYA Biosciences
lead INDUSTRY
Principal Investigators
-
Jasgit Sachdev, MD · IDEAYA Biosciences
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-14
- Primary Completion
- 2027-01-07
- Completion
- 2027-02-04
- FDA Drug
- Yes
Countries
- United States
- Australia
- France
- Germany
- South Korea
- Spain
- Taiwan
Study Locations
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