NCT05975073

A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of Anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).

Conditions

• MTAP-null Non-Small-Cell Lung Cancer
• MTAP-null Solid Tumors

Interventions

Type	Name	Description
DRUG	Anvumetostat	Administered PO
DRUG	IDE397	Administered PO

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2023-08-03
• Last updated: 2026-04-07

Locations

27 sites across 7 countries: United States, Australia, Canada, Denmark, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study