Trials / Active Not Recruiting
Active Not RecruitingNCT04794699
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 169 (actual)
- Sponsor
- IDEAYA Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | IDE397 | IDE397 dosed orally |
| DRUG | Sacituzumab govitecan | Intravenous infusion |
Timeline
- Start date
- 2021-04-14
- Primary completion
- 2027-01-07
- Completion
- 2027-02-04
- First posted
- 2021-03-12
- Last updated
- 2026-04-09
Locations
37 sites across 7 countries: United States, Australia, France, Germany, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04794699. Inclusion in this directory is not an endorsement.