Drugs / IDE397
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07277413 | Mar 2026 → Apr 2028 expected | biliary tract cancer, esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastric adenocarcinoma +7 | IDEAYA Biosciences | Recruiting | No outcome recorded |
| Phase 1 | NCT04794699 | Apr 2021 → Jan 2027 expected | cancer | IDEAYA Biosciences | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05975073 | Aug 2023 → Feb 2026 | non-small cell lung carcinoma | Amgen | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2025-09-08 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Positive Data From Phase 1/2 Combination Trial of IDE397, a potential first-in-class MAT2A inhibitor, and Trodelvy® in MTAP-Deletion Urothelial Cancer ideayabio.com ↗
Overall response rate ( ORR ) of 57% (4/7; 3cPR+1uPR) in patients treated with a combination of 30 mg IDE397 plus 7.5mg/kg Trodelvy ® (Dose level 2); |
| 2024-10-25 | IDEAYA Biosciences | Results IDEAYA Announces Positive Interim Phase 1 Expansion Data of IDE397 in MTAP-Deletion Urothelial and Lung Cancer as Late-Breaker Oral Presentation at EORTC-NCI-AACR 2024 ideayabio.com ↗ |
| 2024-08-06 | IDEAYA Biosciences | Results IDEAYA Biosciences, Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update ideayabio.com ↗
Demonstrated preliminary proof-of-concept for IDE397 in MTAP urothelial and lung cancer; 1 PR awaiting confirmation has confirmed and 1 additional PR still awaiting confirmation, from the 2 uPRs noted in the July 8, 2024 webcast |
| 2024-07-08 | IDEAYA Biosciences | Results IDEAYA Announces Positive Interim Phase 2 Monotherapy Expansion Data for IDE397 a Potential First-in-Class MAT2A Inhibitor in MTAP-Deletion Urothelial and Lung Cancer ideayabio.com ↗
IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced positive clinical data for the IDE397 Phase 2 monotherapy expansion dose in methylthioadenosine phosphorylase (MTAP)-deletion urothelial and non-small cell lung cancer (NSCLC) patients. |
| 2024-04-22 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Selection of Move-Forward Phase 2 Expansion Dose for IDE397 Monotherapy in MTAP-Deletion Squamous Non-Small Cell Lung Cancer ideayabio.com ↗
IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced selection of a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous non-small cell lung cancer (NSCLC), based on adverse event profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1. |
| 2023-10-23 | IDEAYA Biosciences | Results IDEAYA Announces Top-Line Phase 2 Results at ESMO 2023 of Darovasertib and Crizotinib Combo in MUM, and Clinical Efficacy Updates for Neoadjuvant UM, GNAQ/11 Cutaneous Melanoma, and Synthetic Lethality Pipeline ideayabio.com ↗
Synthetic Lethality: Updates on PRs by RECIST 1.1 for IDE397/MAT2A and IDE161/PARG |
| 2023-05-22 | IDEAYA Biosciences | Regulatory IDEAYA Announces IND Clearance Enabling Phase 1/2 Clinical Trial for Combination of IDE397 and AMG 193 in MTAP-Deletion Solid Tumors ideayabio.com ↗ |
| 2022-07-27 | IDEAYA Biosciences | Results IDEAYA Announces IDE397 Clinical Program Update and ctDNA Molecular Responses Demonstrating Tumor Pharmacodynamic Modulation ideayabio.com ↗
ctDNA Molecular Responses observed in 3 of 4 (75%) patients in Cohorts 5 and 6, demonstrating target engagement and tumor pharmacodynamic modulation |
| 2022-03-15 | IDEAYA Biosciences | Results IDEAYA Biosciences Reports IDE397 Interim Phase 1 Clinical Data ideayabio.com ↗
Interim IDE397 clinical data demonstrates robust plasma pharmacodynamic modulation, exceeding target of >60% reduction of plasma SAM across all evaluated cohorts |
| 2021-06-28 | IDEAYA Biosciences | Results IDEAYA Announces IDE397 Phase 1 Clinical Pharmacodynamic Data and Phase 2 Initiation of Darovasertib and Crizotinib Combination ideayabio.com ↗
The observation of a clinical pharmacodynamic signal in the initial cohorts of the IDE397 dose escalation study is significant. |
| 2021-03-11 | IDEAYA Biosciences | Results IDEAYA Announces Presentations at AACR Annual Meeting 2021 for Synthetic Lethality Programs IDE397 and PARG, and Kinase Inhibitor IDE196 ideayabio.com ↗
MAT2A inhibitor, IDE397, displays broad anti-tumor activity across a panel of MTAP-deleted patient-derived xenografts |
| 2021-02-08 | IDEAYA Biosciences | Regulatory IDEAYA Announces IDE397 IND Clearance by U.S. FDA to Initiate Phase 1 and Appointment of Matthew Maurer, M.D., as Vice President, Head of Clinical Oncology and Medical Affairs ideayabio.com ↗ |
| 2021-01-11 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences Announces Submission of IND Application for MAT2A Development Candidate IDE397 with the U.S. FDA ideayabio.com ↗
The IDE397 IND submission is an important milestone for IDEAYA as we advance our broader synthetic lethality pipeline of potential first-in-class therapies. |
All press releases naming this drug 28 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IDE397 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07277413 ↗ |
| Action | Inhibit | “IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).” NCT04794699 ↗ |
| Modality | Small molecule | “IDE397 is a small molecule inhibitor” NCT04794699 ↗ |
| Route | Oral | “IDE397 dosed orally” NCT04794699 ↗ |
| Target | MAT2A | “inhibitor of methionine adenosyltransferase 2 alpha (MAT2A)” NCT04794699 ↗ |