NCT07277413

A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: IDEAYA Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.

Detailed description

The purpose of this study is to evaluate safety, efficacy, and PK of IDE892 as monotherapy and combination therapy in adult participants with MTAP-deleted tumors who have progressed after standard therapy and represent a high unmet need. In the current stage, the combination will be focused on IDE892 with IDE397, an oral inhibitor of methionine adenosyltransferase 2A (MAT2A), to fully exploit the vulnerabilities associated with methylthioadenosine (MTA) accumulation in MTAP-deleted tumors while maintaining a substantial therapeutic index. The mechanistic rationale for this study is discussed in the following sections.

Conditions

• NSCLC Adenocarcinoma
• Gastroesophageal Cancer (GC)
• Gastric Adenocarcinoma
• Adenocarcinoma of Esophagus
• Squamous Cell Car. - Esophagus
• Urothelial Carcinoma (UC)
• Bladder Cancer
• Mesothelioma
• Pleural Mesothelioma
• Peritoneal Mesothelioma
• Non-Small Cell Lung Cancer NSCLC

Interventions

Type	Name	Description
DRUG	IDE892	IDE892 is an inhibitor of the Protein arginine methyltransferase 5 (PRMT5) that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions.
DRUG	IDE397	IDE397 is an oral MAT2A inhibitor that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions. In this study, IDE397 will be evaluated in combination with IDE892 (Parts 3 and 4) in participants with MTAP-deleted advanced solid tumors.

Timeline

• Start date: 2026-03-04
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2025-12-11
• Last updated: 2026-04-03

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study